EU's CHMP Clears Selincro And Perjeta, Rejects Kynamro And Fanaptum
This article was originally published in The Pink Sheet Daily
Europe's top scientific advisory panel backed Lundbeck's alcoholism therapy Selincro (nalmefene) and Roche's next-generation breast cancer therapy Perjeta (pertuzumab) but rejected Genzyme/Isis' antisense therapy Kynamro (mipomersen) and Vanda's Fanaptum (oral iloperidone).
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NICE's positive recommendation for Lundbeck's Selincro for alcohol dependence should give the Danish biotech a revenue boost and help offset expiry of its Lexapro/Cipralex patent.
Roche’s Perjeta suffered a knock-back in Europe when NICE said the clinical trial population was not wholly relevant to the patient population in the UK.
Positive opinions from Europe's top drug assessment panel in May have included a long-acting "biobetter" lipegfilgrastim from Teva, a once-weekly HGH injection from Biopartners GmbH, and a smallpox vaccine developed by Bavarian Nordic with funding from the U.S. BioShield program.