One Of Biotech Industry’s Oldest Companies Has Never Secured A FDA Drug Approval–And It Was Just Dealt Another Rejection
The FDA's rejection of Immunomedics' drug designed to treat aggressive breast cancer cements a 37-year drug development drought for the biotech company. In other news, a FDA advisory panel splits over a decision on approving a diabetes drug.
Stat:
FDA Rejects Immunomedics Breast Cancer Drug, Extending Long Drought
The 37-year drug development drought lives on. Immunomedics (IMMU), the biotech founded in 1982, was informed by the Food and Drug Administration on Thursday night that its lead drug, an antibody drug conjugate to treat women with an aggressive form of breast cancer, could not be approved at this time. The problem: unresolved manufacturing issues related to the drug, called sacituzumab govitecan. (Feuerstein, 1/17)
The New York Times:
F.D.A. Panel Splits On Whether To Approve New Diabetes Drug
An advisory panel for the Food and Drug Administration split evenly on Thursday over whether the agency should approve the first oral medication to treat Type 1 diabetes. The committee voted 8-8, leaving it up to the agency to decide by the end of March whether the drug, sotagliflozin, should reach the market. The drug, which is used along with insulin, is being developed by the drug makers Sanofi and Lexicon Pharmaceuticals, who plan to sell it under the brand name Zynquista. (Thomas, 1/17)
And in drug pricing news —
The Wall Street Journal:
Drugmakers Raise Prices Amid Shortages, Recalls
Drugmakers have sharply boosted prices of some older, low-cost prescription medicines amid supply shortages and recalls—in some cases, by threefold and more. At least three sellers of a widely used blood-pressure medication, valsartan, have raised prices since a series of safety-related recalls of the drug by other manufacturers began in the summer of 2018. Virtus Pharmaceuticals in May jacked up the U.S. price of a bottle of a muscle relaxant that has been in short supply, methocarbamol, by 1,137% to $105. It was the biggest percentage price increase for a prescription medicine in 2018, according to a new analysis of pricing data. (Loftus, 1/18)
Kaiser Health News:
Secretive ‘Rebate Trap’ Keeps Generic Drugs For Diabetes And Other Ills Out Of Reach
Lisa Crook was lucky. She saved $800 last year after her insurance company started covering a new, less expensive insulin called Basaglar that was virtually identical to the brand she had used for years. The list price for Lantus, a long-acting insulin made by Sanofi that she injected once a day, had nearly quadrupled over a decade.With Basaglar, “I’ve never had my insulin cost drop so significantly,” said Crook, a legal assistant in Dallas who has Type 1 diabetes. (Hancock and Lupkin, 1/18)
Kaiser Health News:
Podcast: KHN’s ‘What The Health?’ Drug Prices Are Rising Again. Is Someone Going To Do Something About It?
Many drugmakers have announced price increases with the start of the new year. The new Congress wants to do something about that. And even though both Republicans and Democrats want to address the politically potent issue of drug prices, it is unclear what they might be able to agree on. Battle lines are forming between the House and Senate on the matter of abortion. The House is led by abortion-rights supporters and, since the election, the Senate has become slightly more against abortion. (1/17)
Stat:
Groups Opposing Medicare Part D Talks Criticized For Not Disclosing Industry Ties
Earlier this week, the National Osteoporosis Foundation wrote members of Congress on behalf of more than 200 organizations to express concern over efforts that would allow Medicare to negotiate prices for the Part D drug program. Specifically, the letter objected to eliminating what is known as the non-interference clause, which prevents the government from negotiating drug prices for Part D. In its note, the organization argued this is a “crucial fixture and protection. … We are very concerned that these changes would have harmful effects on patients and lead to larger access and adherence issues.” (Silverman, 1/17)