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Busy FDA Week Ends With Two Drug Approvals: Another Might Be on Way

Xconomy Boston — 

The new FDA commissioner Robert Califf told a conference audience this week that he expected “a flood” of new treatments in the near future. Perhaps he meant the following few days. His agency approved two drugs to close out the week, and another decision is due by Sunday.

The FDA announced late Friday afternoon that a treatment for multiple sclerosis called daclizumab (Zinbryta) has the green light to hit the market. Developed by Biogen (NASDAQ: BIIB) and AbbVie (NYSE: ABBV), daclizumab is a monthly self-administered injection, but it has dangerous side effects and is only meant for people whose disease has not responded well to at least two other therapeutics. It is approved for relapsing-remitting MS, which is characterized by acute neurologic attacks and periods of complete or partial recovery.

The most serious side effects of daclizumab are severe liver injury and immune reactions, according to the FDA. Doctors will need to check a patient’s liver function with blood tests before prescribing the drug. Another version of daclizumab, marketed as Zenapax by Roche in the previous decade to prevent rejection of transplanted kidneys, was taken off the market in 2009.

No price for daclizumab was disclosed. “We expect the price to be available closer to the third quarter,” AbbVie spokesman Jack Hirschfield said.

The agency approved Thursday a subcutaneous implant that releases buprenorphine for up to six months as a treatment for opioid addiction. The implant is from San Francisco’s Titan Pharmaceuticals (NASDAQ: [[ticker:TTNP]]) and partner Braeburn Pharmaceuticals, of Princeton, NJ. The approval marks a return from the abyss for Titan, as the San Francisco Business Times reported yesterday. Braeburn will do the marketing, and it plans to offer insurers a pay-for-performance price scheme that might be difficult to put in place, as Stat reported earlier this week.

Intercept Pharmaceuticals (NASDAQ: ICPT) of New York is up next. Its liver disease drug obeticholic acid (OCA) is under FDA review and received a big thumbs-up from a panel of outside advisors last month. A final decision is due by Sunday.

The agency approved 45 new drugs last year and 41 the year before, a huge spike in activity that pleased industry advocates and concerned others that regulation has grown too lax. It has approved 11 so far this year pending the OCA decision.

The biggest FDA drug news this week came not from an approval, however, but from the agency’s decision to delay judgment on eteplirsen, an experimental drug for Duchenne muscular dystrophy. The delay came amid pressure from politicians and patient groups. There is no drug approved for the rare, deadly disease.

Photo of FDA headquarters by This is Bossi via Creative Commons.