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Eye risk with Vertex cystic fibrosis drug: FDA

August 29th, 2012

WASHINGTON | Wed Aug 29, 2012 10:40am EDT WASHINGTON (Reuters) – U.S. officials warned that children taking Vertex Pharmaceuticals Inc’s cystic fibrosis drug may be at risk of getting cataracts, based on a study in juvenile rats.

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FDA staff questions dosing of Roche eye drug

July 24th, 2012

By Anna Yukhananov WASHINGTON | Tue Jul 24, 2012 10:18am EDT WASHINGTON (Reuters) – U.S.

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FDA focuses on training to stem painkiller abuse

July 9th, 2012

By Anna Yukhananov WASHINGTON | Mon Jul 9, 2012 4:59pm EDT WASHINGTON (Reuters) – Health regulators are hoping more education for doctors and patients can stem the growing tide of prescription painkiller abuse in the United States. The Food and Drug Administration is mandating that all companies that make long-acting or extended-release opioid medicines – including painkillers like oxycodone and methadone – fund training programs for doctors and distribute info sheets for patients that promote proper use of the pills

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FDA warns MS patients about risky treatment

May 10th, 2012

By Anna Yukhananov WASHINGTON | Thu May 10, 2012 12:03pm EDT WASHINGTON (Reuters) – U.S. drug regulators are warning people with multiple sclerosis that an experimental treatment that props open internal veins in the neck and chest can cause death or serious injury. The Food and Drug Administration on Thursday said at least two people had died from the procedure, which uses stents or balloon angioplasties to widen veins that connect the brain and spinal cord to the heart.

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FDA staff focus on safety of Astellas bladder drug

April 3rd, 2012

By Anna Yukhananov WASHINGTON | Tue Apr 3, 2012 9:45am EDT WASHINGTON (Reuters) – Drugs reviewers said Astellas Pharma Inc’s treatment for an overactive bladder worked, but they raised concerns about liver and heart safety issues. The Food and Drug Administration staff said the once-daily tablet, called mirabegron, worked to reduce frequent urination and the inability to control it, according to documents released online on Tuesday. But the pill, already approved in Japan, was also tied to a higher rate of neoplasms, or tumors, urinary tract problems and hypersensitivity reactions, according to the FDA staff.

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FDA panel says pain drug trials should continue

March 12th, 2012

By Anna Yukhananov Mon Mar 12, 2012 6:34pm EDT (Reuters) – A panel of advisers on Monday voted unanimously that companies such as Pfizer Inc and Regeneron Pharmaceuticals Inc should be allowed to continue testing a type of painkiller that helps people but can destroy joints. The advisers to the U.S

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Funding bill may address drug shortages-aides

February 1st, 2012

By Anna Yukhananov WASHINGTON | Tue Jan 31, 2012 7:14pm EST WASHINGTON (Reuters) – Legislation aimed at relieving shortages of crucial drugs used to treat cancer and other illnesses may get momentum next week when lawmakers decide whether to attach it to a must-pass funding bill for the U.S. Food and Drug Administration, congressional aides said on Tuesday. A House of Representatives hearing next week about FDA funding will address the shortage of life-saving medicines, said the aides, who spoke on condition of anonymity. The number of drugs in short supply rose to 220 in 2011 from 56 in 2006, the year a clear trend started emerging. Some doctors have had to postpone care or use second-best drugs or more costly alternatives to compensate for shortages. President Barack Obama made shortages a national priority with an executive order in October, and urged Congress to quickly pass legislation to address the issue. Two bills that would force drug companies to tell the FDA about looming shortages have been stuck in a deadlocked Congress this year, despite bipartisan support. A third bill was introduced on Tuesday. Next week’s House hearing is part of the process to renew FDA user fees, or the funds companies pay to the agency in exchange for faster review of drugs and devices. Congress must renew the Prescription Drug User Fee Act (PDUFA) every five years. The current legislation is due to expire in September. “We’re hoping that the user fee bill can be a vehicle for the (drug shortages) language,” said one congressional staffer familiar with the matter. Since fees from makers of drugs and medical devices provide more than a third of the FDA’s funding, the bill often serves as a vehicle for broader FDA-related changes. The Senate is also working on including the issue of drug shortages in the FDA user fee legislation, another aide said. On Tuesday, Representatives John Carney, a Democrat from Delaware, and Larry Bucshon, a Republican from Indiana, proposed the third drug shortages bill. Among other measures, this legislation would force the FDA to speed up its review of applications from companies that want to change or ramp up production to address shortages. It would also require the Drug Enforcement Administration (DEA) to raise its quota for certain controlled substances if they are needed for a drug in short supply. Manufacturers have said the DEA’s quota system has prevented them from increasing production of drugs such as Adderall to treat attention deficit hyperactivity disorder. “Certainly the user fee reauthorization is the most likely course of action” to get Carney and Bucshon’s bill passed, a third aide said. (Reporting by Anna Yukhananov) Link this Share this Digg this Email Reprints

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US FDA approves Amylin’s diabetes drug

January 27th, 2012

By Anna Yukhananov WASHINGTON | Fri Jan 27, 2012 4:49pm EST WASHINGTON (Reuters) – Amylin Pharmaceuticals won U.S. approval on Friday for its Bydureon diabetes drug, a long-awaited victory for the company’s most promising product. After two delays, the Food and Drug Administration approved once-weekly injectable Bydureon for treating adults with Type 2 diabetes, the kind linked to poor diet and lack of exercise. Bydureon is a longer-acting form of Amylin’s older Byetta treatment. Shares of Amylin and partner Alkermes, which provided some technology for the medicine, were halted ahead of the announcement of the FDA’s decision. More than 300 million people worldwide suffer from diabetes, including nearly 26 million Americans. They run a high risk of heart disease, stroke, kidney failure, blindness and limb loss. Bydureon is seen as Amylin’s most important new drug, and critical to its future earnings growth, with analysts estimating peak sales of close to $1 billion. But after repeated delays in gaining approval in the United States, the medicine faces a daunting competitive landscape. Novo Nordisk’s Victoza, another injectable diabetes medicine, has had almost two extra years to gain traction with patients and doctors. The delays have also given time for potential rivals from GlaxoSmithKline Plc and Sanofi to catch up. The FDA had rejected Bydureon twice before, most recently in October 2010, asking for more data on potential side effects to the heart. A trial of Bydureon in July found no link between the drug and changes in heart rhythms, the company said. However, as a condition of approval, the FDA on Friday said Amylin must conduct another long-term clinical trial by 2018 to study heart-related side effects from Bydureon. WITHOUT LILLY Taken once a week, Bydureon has been viewed as crucial to sustaining the franchise started by the twice-daily Byetta. Investors are closely watching whether Amylin will be able to pull off a successful launch without the help of long-time partner Eli Lilly & Co after the two companies broke off their diabetes partnership in November. Alkermes would also get royalties from the sales of Bydureon. Amylin said Bydureon would be available in U.S. pharmacies starting in February. Victoza, which is injected daily, proved superior to Bydureon in controlling blood sugar levels, trial results published last March showed. But Bydureon may get a boost because of its more convenient dosing. Analysts at Deutsche Bank said they expect peak Bydureon sales of $1.5 billion, above market forecasts of $940 million by 2016, because of its convenience compared with Victoza. Bydureon, Byetta and Victoza belong to the new GLP-1 class of therapies that stimulate insulin production when blood sugar levels become too high. They can also prompt weight loss, a benefit because obesity is a leading cause of diabetes. European regulators approved Bydureon as a treatment for Type 2 diabetes in April 2011. (Reporting by Anna Yukhananov, additional reporting by Deena Beasley in Los Angeles; Editing by Tim Dobbyn and Stever Orlofsky) Link this Share this Digg this Email Reprints

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Drug lobby wants clearer FDA rules for diet pills

January 20th, 2012

By Anna Yukhananov WASHINGTON | Fri Jan 20, 2012 12:19am EST WASHINGTON (Reuters) – The pharmaceutical industry may stop investing in medicines to treat diseases like diabetes or obesity without more explicit guidelines from U.S. regulators, the chairman of the drug trade group said on Thursday. The Food and Drug Administration must approve any medical products sold in the United States, but drug companies say they cannot always predict how the agency weighs risks and benefits for medicines that could be widely used. To avoid the uncertainty, companies may focus on specialized cancer drugs, where it is clear patients and the FDA are willing to accept serious side-effects in exchange for potentially life-saving treatments. “You’re starting to see primary care diseases becoming somewhat neglected,” said Christopher Viehbacher, chairman of the board of the Pharmaceutical Research and Manufacturers of America (PhRMA), in an interview. “To make sure we’re not ignoring unmet needs in primary care, we need a lot more clarity around the risk-benefit so there’s predictability when we invest in these products,” said Viehbacher, also chief executive of French drugmaker Sanofi SA. PhRMA and other groups are gearing up their lobbying strategy ahead of Congressional hearings on FDA user fees, or the funds companies pay to the agency in exchange for faster review times. Since fees from makers of drugs and medical devices provide more than a third of the agency’s funding, the bill often serves as a vehicle for broader FDA-related changes. Congress must renew the Prescription Drug User Fee Act (PDUFA) every five years, with the current legislation expiring in September 2012. Over the past year, the FDA has drawn fire from some manufacturers for being too cautious in reviewing medical products, hindering U.S. innovation. They point to obesity drugs, where Arena Pharmaceuticals, Orexigen Therapeutics and Vivus have hit roadblocks in gaining approval for their diet pills because of potential safety concerns. About a third of U.S. adults are obese and medicines could help manage the weight along with diet and exercise. Viehbacher said the FDA is aware of the challenge of balancing patient safety and innovation. “You’re hearing the FDA say that yes, we need to protect patients, and yes, we need to keep medicines accessible,” he said. “I don’t think anybody has to sacrifice. I think there just has to be a lot more science.” (Reporting by Anna Yukhananov; Editing by Matt Driskill) Link this Share this Digg this Email Reprints

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