U.S. panel backs Forest Labs drug for smoker's cough

SILVER SPRING, Maryland (Reuters) - An experimental inhaled lung treatment from Forest Laboratories Inc and Almirall SA won the support of a U.S. advisory panel on Thursday, a boost toward eventually gaining approval for the drug to treat smoker's cough.

A panel of outside expert advisers to the Food and Drug Administration voted 12-2 to recommend approval of the twice-daily drug, known generically as aclidinium bromide.

The drug treats chronic obstructive pulmonary disease (COPD), commonly called smoker's cough as it is often caused by cigarette smoking. It is the fourth-leading killer of Americans from disease.

Panelists said the lung helped patients breathe, but called for the company to do post-approval studies to test safety because some patients died from heart problems during clinical trials.

"I think the efficacy is modest, but with COPD treatments, the efficacy tends to be modest," said panel member Dr. William Calhoun, professor at the University of Texas Medical Branch.

"It seems to me that the critical question here is the safety issue."

The FDA usually follows panel recommendations, although it is not required to, and a final decision is expected by April 23.

Shares of Forest, which has a licensing agreement with Almirall to market the drug in the United States, closed up 1.2 percent at $32.21 on the New York Stock Exchange.

Forest is counting on new treatments such as aclidinium to help prop up profits after its blockbuster antidepressant Lexapro is expected to lose U.S. patent protection this year.

Up to 24 million people in the United States, and more than 100 million worldwide, suffer from COPD, which gets worse with age and can persist even if patients stop smoking.

Wall Street expects global sales of COPD treatments to exceed $5 billion in 2014.

COMPETING FOR SMOKERS

FDA staff reviewers earlier this week raised concerns about potential heart problems linked to drugs in the same class.

In the clinical trials for Forest and Almirall's lung drug, four patients taking the drug died from cardiac arrest and one from heart failure, out of a total of about 1,500 people who took the 400 microgram dose of the inhaled powder.

FDA staff said clinical trials may not have been big enough to show whether the problems came from the drug, or because patients with the disease may also have heart problems.

If approved, Forest's drug, which the company plans to sell under the name Tudorza Pressair, would compete with Boehringer Ingelheim and Pfizer Inc's Spiriva, which is also an inhaled drug that opens airways.

Other treatments for chronic lung disease are inhaled steroids such as AstraZeneca Plc's Symbicor and GlaxoSmithKline Plc's Advair.

Forest gained U.S. approval last year for Daliresp, a tablet that treats exacerbations caused by chronic lung disease.

"Today shows our commitment to the COPD community with a second product to treat a very common disease," said Dr. Marco Taglietti, senior vice president for research and development at Forest Laboratories.

"Certainly we're very pleased the committee has agreed the product is effective and has adequate safety to be approved."

(Reporting by Anna Yukhananov; editing by Gary Hill and Andre Grenon)

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FDA panel backs previously rejected obesity pill

SILVER SPRING, Md. (AP) — A previously rejected weight loss pill won an overwhelming endorsement from public health advisers Wednesday, raising hopes that the drug from Vivus Inc. could become the first new anti-obesity medication to reach the U.S. market in more than a decade.

The Food and Drug Administration has rejected three weight loss pills in the last two years, including Vivus' pill Qnexa, due to safety concerns. Experts agree new weight loss drugs are needed to treat an estimated 75 million obese adults in the U.S., but the string of rejections has raised questions of whether any pharmaceutical treatment is safe enough to win approval.

At a public meeting Wednesday, an FDA panel of outside physicians voted 20-2 in favor of the weight loss drug from Vivus, setting the stage for a potential comeback for a drug that has been plagued by safety questions since it was first submitted to the agency in 2010.

Nearly all the panelists backed the drug due to its impressive weight loss results, with most patients losing nearly 10 percent of their overall weight after a year on the drug. But the group stressed that the drugmaker must be required to conduct a large, follow-up study of the pill's effects on the heart. Studies of Qnexa show it raises heart rate and causes heart palpitations, a longtime concern with diet pills over the years. The group of experts said it is still unclear if those side effects lead to heart attack and more serious cardiovascular problems.

"The potential benefits of this medication seem to trump the side effects, but in truth, only time will tell," said Dr. Kenneth Burman of the Washington Hospital Center.

The FDA is not required to follow the advice of its panels, though it often does. A final decision on the drug is expected by mid-April.

In a key question, the physicians said Vivus could conduct the cardiovascular safety study after FDA approval. A requirement to conduct the study ahead of market approval would cost the company millions of dollars and take at least three more years.

"There is an urgent need for better pharmacologic options for individual patients with obesity," said Dr. Elaine Morrato, of the University of Colorado. "I believe Qnexa demonstrated a meaningful efficacy benefit and that there are consequences to not treating obesity."

Vivus, based in Mountain View, Calif., is one of three small drugmakers racing to bring the first new prescription weight loss drug to market in more than a decade. In the past two years the Food and Drug Administration has rejected pills from all three: Arena Pharmaceuticals Inc., Orexigen Therapeutics Inc. and Vivus. All three companies are in the process of resubmitting their products.

The FDA rejected Qnexa in October 2010, citing numerous side effects including elevated heart rate, psychiatric problems and birth defects. Vivus has resubmitted the drug with additional follow-up information on safety, hoping for a more favorable ruling.

Vivus President Peter Tam said the overwhelming panel vote Wednesday indicates doctors recognize the urgent need for effective weight loss drugs.

"Right now there aren't any good treatments out there besides dieting and bariatric surgery — clearly there's a huge gap," Tam said.

With U.S. obesity rates nearing 35 percent among adults, doctors and public health officials say new weight-loss therapies are desperately needed. And even a modestly effective drug could have blockbuster potential. Analysts expect a new weight loss pill to garner at least 10 million users within a few years.

Qnexa is a combination of two older drugs: the amphetamine phentermine, which is approved for short-term weight loss, and topiramate, an anti-seizure and anti-migraine drug sold by Johnson & Johnson as Topamax. Phentermine helps suppress appetite, while topiramate is supposed to make patients feel more satiated.

Along with heart safety, panelists raised concerns about potential birth defects in women who become pregnant while taking Qnexa: topiramate is known to more than double the risk of birth defects.

There were 34 pregnancies among 3,386 women enrolled in Vivus' studies of Qnexa, despite precautions to make sure women used contraception. An FDA expert on birth defects estimated there would be five babies born with a cleft lip defect for every 1,000 women who became pregnant while taking Qnexa.

If approved, FDA scientists said they would require Vivus to train prescribers to educate patients on the pregnancy risks of Qnexa. The drug would only be available from 10 mail-order pharmacies.

Qnexa's other ingredient, phentermine, was one half of the dangerous fen-phen combination, a weight loss treatment pushed by doctors that was never approved by the FDA. The regimen was linked to heart-valve damage and lung problems in the late 1990s, and the FDA forced drugmaker Wyeth to withdraw two versions of its drug fenfluramine.

Fen-phen is just one example in the decadeslong history of failed weight loss drugs, which have continued to pile up in recent years.

Four years ago Sanofi-Aventis SA discontinued studies of its highly anticipated pill Acomplia due to psychiatric side effects, including depression and suicidal thoughts. In 2010, Abbott Laboratories withdrew its drug Meridia after a study showed it increased heart attack and stroke. The drug won approval in 1997 in the wake of the recall of fenfluramine but never achieved widespread use due to modest weight loss and safety concerns. Only 100,000 prescriptions were written in the U.S. during Meridia's last full-year on the market.

Currently there is just one prescription drug on the market for long-term weight loss: Roche's Xenical, which is sold over the counter as alli by GlaxoSmithKline. The drug is not widely used because of modest weight loss results and unpleasant side effects, including gas and diarrhea.

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FDA panel backs previously rejected obesity pill

SILVER SPRING, Md. (AP) — A previously rejected weight loss pill won an overwhelming endorsement from public health advisers Wednesday, raising hopes that the drug from Vivus Inc. could become the first new anti-obesity medication to reach the U.S. market in more than a decade.

The Food and Drug Administration has rejected three weight loss pills in the last two years, including Vivus' pill Qnexa, due to safety concerns. Experts agree new weight loss drugs are needed to treat an estimated 75 million obese adults in the U.S., but the string of rejections has raised questions of whether any pharmaceutical treatment is safe enough to win approval.

At a public meeting Wednesday, an FDA panel of outside physicians voted 20-2 in favor of the weight loss drug from Vivus, setting the stage for a potential comeback for a drug that has been plagued by safety questions since it was first submitted to the agency in 2010.

Nearly all the panelists backed the drug due to its impressive weight loss results, with most patients losing nearly 10 percent of their overall weight after a year on the drug. But the group stressed that the drugmaker must be required to conduct a large, follow-up study of the pill's effects on the heart. Studies of Qnexa show it raises heart rate and causes heart palpitations, a longtime concern with diet pills over the years. The group of experts said it is still unclear if those side effects lead to heart attack and more serious cardiovascular problems.

"The potential benefits of this medication seem to trump the side effects, but in truth, only time will tell," said Dr. Kenneth Burman of the Washington Hospital Center.

The FDA is not required to follow the advice of its panels, though it often does. A final decision on the drug is expected by mid-April.

In a key question, the physicians said Vivus could conduct the cardiovascular safety study after FDA approval. A requirement to conduct the study ahead of market approval would cost the company millions of dollars and take at least three more years.

"There is an urgent need for better pharmacologic options for individual patients with obesity," said Dr. Elaine Morrato, of the University of Colorado. "I believe Qnexa demonstrated a meaningful efficacy benefit and that there are consequences to not treating obesity."

Vivus, based in Mountain View, Calif., is one of three small drugmakers racing to bring the first new prescription weight loss drug to market in more than a decade. In the past two years the Food and Drug Administration has rejected pills from all three: Arena Pharmaceuticals Inc., Orexigen Therapeutics Inc. and Vivus. All three companies are in the process of resubmitting their products.

The FDA rejected Qnexa in October 2010, citing numerous side effects including elevated heart rate, psychiatric problems and birth defects. Vivus has resubmitted the drug with additional follow-up information on safety, hoping for a more favorable ruling.

Vivus President Peter Tam said the overwhelming panel vote Wednesday indicates doctors recognize the urgent need for effective weight loss drugs.

"Right now there aren't any good treatments out there besides dieting and bariatric surgery — clearly there's a huge gap," Tam said.

With U.S. obesity rates nearing 35 percent among adults, doctors and public health officials say new weight-loss therapies are desperately needed. And even a modestly effective drug could have blockbuster potential. Analysts expect a new weight loss pill to garner at least 10 million users within a few years.

Qnexa is a combination of two older drugs: the amphetamine phentermine, which is approved for short-term weight loss, and topiramate, an anti-seizure and anti-migraine drug sold by Johnson & Johnson as Topamax. Phentermine helps suppress appetite, while topiramate is supposed to make patients feel more satiated.

Along with heart safety, panelists raised concerns about potential birth defects in women who become pregnant while taking Qnexa: topiramate is known to more than double the risk of birth defects.

There were 34 pregnancies among 3,386 women enrolled in Vivus' studies of Qnexa, despite precautions to make sure women used contraception. An FDA expert on birth defects estimated there would be five babies born with a cleft lip defect for every 1,000 women who became pregnant while taking Qnexa.

If approved, FDA scientists said they would require Vivus to train prescribers to educate patients on the pregnancy risks of Qnexa. The drug would only be available from 10 mail-order pharmacies.

Qnexa's other ingredient, phentermine, was one half of the dangerous fen-phen combination, a weight loss treatment pushed by doctors that was never approved by the FDA. The regimen was linked to heart-valve damage and lung problems in the late 1990s, and the FDA forced drugmaker Wyeth to withdraw two versions of its drug fenfluramine.

Fen-phen is just one example in the decadeslong history of failed weight loss drugs, which have continued to pile up in recent years.

Four years ago Sanofi-Aventis SA discontinued studies of its highly anticipated pill Acomplia due to psychiatric side effects, including depression and suicidal thoughts. In 2010, Abbott Laboratories withdrew its drug Meridia after a study showed it increased heart attack and stroke. The drug won approval in 1997 in the wake of the recall of fenfluramine but never achieved widespread use due to modest weight loss and safety concerns. Only 100,000 prescriptions were written in the U.S. during Meridia's last full-year on the market.

Currently there is just one prescription drug on the market for long-term weight loss: Roche's Xenical, which is sold over the counter as alli by GlaxoSmithKline. The drug is not widely used because of modest weight loss results and unpleasant side effects, including gas and diarrhea.

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FDA panel votes against wider use of Amgen drug

WASHINGTON (Reuters) - An advisory panel on Wednesday recommended that U.S. health regulators reject the use of Amgen Inc's drug Xgeva to delay the spread of prostate cancer to the bone, dimming the chance of a wider use for one of the company's key growth drivers.

The outside advisers to the Food and Drug Administration voted 12-to-1 that the benefits of the injectable drug, known chemically as denosumab, did not outweigh the risk of developing a jawbone-destroying condition.

Xgeva is already approved to prevent fractures and related problems in advanced prostate cancer that has spread to the bone, and the company is seeking additional approval for use of the drug to delay or prevent the spread.

The drug did delay the spread of cancer to the bone by a little longer than four months in a clinical trial of 1,432 men with prostate cancer who had stopped responding to hormone therapy.

But about one in 15 men who took the drug developed osteonecrosis of the jaw, a severe side effect in which jawbone tissue dies, exposing the bone. That rate is far higher than has been seen with widely used osteoporosis drugs.

"If you ask a patient, 'Do you want to delay your disease by five minutes, but get significant toxicities?' I think that would give them pause," said panel member Maha Hussain, a professor of medicine in the hematology and oncology division at the University of Michigan.

The FDA usually follows the recommendations of its expert panels and will make a final decision by April 26.

Most analysts had expected the unfavorable panel vote because the FDA had questioned whether delaying the spread of cancer to the bone was a meaningful benefit to patients given that the drug did not help men live longer or delay the growth of prostate cancer..

"We believe the panel recommendation reinforces the FDA's view, which has been consistently negative, and approval is unlikely," said Geoff Meacham, analyst at JP Morgan, in a research note.

However, he said the risk of a rejection of wider approval for Xgeva had only a modest risk to his long-term revenue estimates for Amgen, the world's largest biotechnology company.

BENEFIT TO PATIENTS?

Xgeva and a related osteoporosis drug Prolia are seen as among the most important growth drivers for Amgen and are expected to help offset declining sales of the anemia drugs that had been the company's backbone.

In the fourth quarter of 2011, sales of Xgeva rose to $134 million from $100 million in the prior quarter, and it is expected to eventually become a $1 billion-a-year drug.

The company said the new use for Xgeva would be targeted at about 50,000 men in the United States at that advanced stage of the disease.

Panel members questioned whether using the drug earlier actually benefited patients, as many did not have symptoms of the disease, but would suffer any drug-related side effects.

However, the patient representative on the panel voted in favor of approval.

"There isn't a treatment that a man with prostate cancer gets that doesn't have devastating effects on his masculinity and his quality of life," said James Kiefert, of Olympia, Washington. "In my opinion, the men who would be candidates for this treatment would be standing up and cheering another option for them."

His views echoed the favorable comments of several urologists, who testified in favor of the drug during the public hearing.

Amgen said Xgeva provided a meaningful benefit to prostate cancer patients by preventing the spread of their disease to the bones, which is not uncommon.

"We look forward to further discussions with the FDA as they continue to review our application," the company said in a statement after the vote.

If Xgeva gains wider approval, it would be the first drug to delay the spread of prostate cancer to the bone, Amgen said.

Amgen said it was also testing Xgeva in other cancers, including breast and lung cancer and the blood cancer multiple myeloma.

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