Three months after an FDA advisory panel’s vote of confidence, FDA has approved Novo Nordisk’s Saxenda (liraglutide 3mg) for treating chronic obesity. A lower-dose form of Novo’s top-selling GLP-1 diabetes treatment Victoza (liraglutide 1.2mg and 1.8mg), Saxenda is approved with a REMS, will require a suite of post-marketing studies, and comes with a boxed warning that thyroid gland tumors have been observed in rodent studies.
While surveyed health plans are applauding the cost-cutting implications of Express Scripts’ move to make AbbVie’s new hep-C. regimen the exclusive option on its national formulary for members with the genotype-1 form of the virus, doctors have mixed views on the PBM’s initiative, according to a poll conducted for the Wall Street Journal’s Pharmalot blog. An advantage of the new formulary is that patients at all stages of the disease will be covered, whereas payers have denied coverage of the oral therapies or paid for Sovaldi and Harvoni only for patients in the advanced stage, some doctors noted. On the negative side, however, treatment with AbbVie’s Viekira Pak will be tougher to manage, as some patients are taking as many as six pills, including ribavirin, doctors said, vs. only one for Harvoni.
Janssen and Gilead Sciences announced an R&D collaboration on two fronts for HIV treatments. As part of an amendment to a 2011 agreement, Janssen R&D Ireland will take over clinical development of the once-daily, single-tablet regimen combining Prezista, cobicistat, emtricitabine and tenofovir alafenamide and, with approval, will handle manufacturing and commercialization worldwide. (The pill has completed Phase-I and -II studies.) Also, in an expansion of a 2009 agreement, Gilead’s tenofovir alafenamide (TAF) will replace tenofovir disoproxil fumarate in the biotech firm’s HIV med Complera. TAF exhibits a better renal and bone safety profile, the companies said. Gilead will take on development and commercialization in most countries for the investigational combination.
Vanda Pharma has regained rights to its schizophrenia drug Fanapt (iloperidone) after settlement of license arbitration with Novartis, which had purchased exclusive US and Canadian rights in 2009, firms said. Along with the rights transfer, Novartis will make a $25-million investment in Vanda, and grant it an exclusive license to an alpha-7 nicotinic acetylcholine receptor partial agonist in development, in a deal Vanda CEO Mihael Polymeropoulos called potentially “transformational” for Vanda.
Galderma Labs has received FDA approval for Soolantra Cream 1% (ivermectin) for rosacea, after a head-to-head study showed the once-daily topical treatment is more efficacious than standard treatment with metronidazole 0.75%.