FDA Staffers Troubled By Top Official’s Rush To Approve Muscular Dystrophy Drug
Documents show that there were concerns Drug Center Director Janet Woodcock was influenced by public pressure. Meanwhile, Sarepta's stock is soaring on the approval news.
FDA Scientists Worry Director Bowed To Political, Financial Pressures In Controversial Drug Approval
FDA’s decision to approve a controversial Duchenne muscular dystrophy drug this week has raised questions within the agency about whether its top drug regulator pushed too aggressively to greenlight an unproven treatment — for a rare disease that kills young people and stirs strong emotions. Internal documents detailing FDA’s decision to ultimately approve the drug for types of Duchenne reveal that critics within the agency saw FDA’s Drug Center Director Janet Woodcock as too influenced by patient advocates, who mounted an aggressive campaign for approval despite shaky evidence of the treatment’s benefits. Some worried that Woodcock let politics and public pressure — and even the drug company’s financial considerations — influence the approval Monday of a $300,000-per-year drug based on questionable science. (Carlin-Smith, 9/20)
Reborn With Its Duchenne Drug, Sarepta Sees Its Stock Soar 14%
Given up for dead just five months ago, Sarepta Therapeutics Inc. has suddenly been reborn as one of the hottest stars in Kendall Square’s biotech constellation. Sarepta’s stock closed near a record high Tuesday, up nearly 14 percent to $55.73, a day after the Food and Drug Administration issued its surprise approval of the company’s experimental drug for Duchenne muscular dystrophy. The run-up boosted Sarepta’s market value to $2.6 billion, and some analysts are now suggesting it may be an attractive takeover candidate. (Weisman, 9/20)
In other pharmaceutical news —
Dallas Morning News:
The Raging Statin Debate: Should You Take A Cholesterol-Lowering Drug?
If you are over the age of 40, chances are you already pop a cholesterol-lowering pill called a statin. An estimated 32 million Americans take statins -- a number equivalent to the combined populations of Texas and Oklahoma. Statins can lower bad cholesterol, known as LDL, by 30 percent and are estimated to prevent thousands of strokes and heart attacks in the U.S. each year. But the medicine is not without controversy. In some studies, as many as one third of people taking statins suffered side effects and half stopped taking the drugs because they had muscle pain, flushing or confusion. In rare cases, some experienced liver damage, memory loss or a breakdown of muscle tissue. Statins can also increase the risk of diabetes, especially in women. (Yasmin, 9/20)
Bayer’s Dermatology Unit Sale Said To Attract Teva And Perrigo
Bayer AG’s dermatology unit is attracting interest from a number of health-care and private equity firms as the German company seeks to raise cash for its $66 billion acquisition of Monsanto Co., according to people with knowledge of the matter. Teva Pharmaceutical Industries Ltd., Perrigo Co. and Sun Pharmaceutical Industries Ltd. are among companies considering offers, said the people, who asked not to be named because the deliberations are private. Buyout firms including KKR & Co., Nordic Capital, Bain Capital, Blackstone Group LP and Cinven Ltd. may also look at the asset, the people said. (Baigorri and Kirchfeld, 9/20)