The regulators have spoken on both sides of the Atlantic. And in both cases, we have winners--and we have losers. On the positive side of the ledger, we find Bayer and its Eylea treatment for macular degeneration and Otsuka's new long-acting version of the antipsychotic Abilify. On the not-so-positive side, there's AbbVie's ($ABBV) Humira and its new indication for spondyloarthritis, plus GlaxoSmithKline's ($GSK) lupus drug Benlysta, among others. Here's more:
- The U.K's. cost-effectiveness agency once again rejected GlaxoSmithKline's lupus treatment Benlysta--even after the company offered a discount. The National Institute for Health and Care Excellence (NICE) said the drug, the first new treatment for lupus in 50 years, wasn't a good value for the money. Release | Report
- Bayer's fast-moving Eylea drug for wet age-related macular degeneration won NICE's backing, allowing it a clear field to compete with Novartis' ($NVS) rival treatment Lucentis. The cost-effectiveness agency said the two drugs are closely matched on cost and efficacy, thanks to discount schemes. Report
- GSK's Revolade treatment got final backing from NICE as a treatment for certain patients with a bleeding disorder known as idiopathic thrombocytopenic purpura. Otsuka's new long-acting version of the antipsychotic drug Abilify also won the agency's final nod. Report
- In draft guidance, NICE said it's "minded not to recommend" Roche's ($RHHBY) MabThera--a.k.a. Rituxan--as a treatment for a rare type of vasculitis. The agency asked for more information from the drugmaker, for consideration at its next appraisal committee meeting. Release
- UCB said an FDA advisory panel voted to recommend approval of broader use of its anti-inflammatory drug Cimzia. If ratified by the agency itself, Cimzia would be clear for marketing as a treatment for axial spondyloarthritis. Report
- The FDA advisory panel voted down a new use for AbbVie's Humira, however. The committee of outside advisers asked AbbVie for additional trials to prove that Humira is effective at treating early stages of axial spondyloarthritis. Humira is AbbVie's most important and best-selling drug, with more than $9 billion in 2012 sales. Report
Special Report: Carole Longson - NICE - The 25 most influential people in biopharma today