The latest set of opinions from the European Medicines Agency’s Committee for Medicinal Products for Human Use include good news for Swiss firms Roche and Basilea and a potential thumbs-up for Novartis’ biosimilar of filgrastim.
First up, the CHMP has granted a positive opinion for RoActemra (tocilizumab), which is known as Actemra elsewhere, for the treatment of adult patients with moderate to severe rheumatoid arthritis when combined with methotrexate. Fellow Basel-headquartered group Basilea was boosted by the committee’s backing for the superbug antibiotic ceftobiprole, which will be marketed as Zevtera.
Staying with Switzerland, Novartis got the panel’s backing for Rasilez HCT, which combines Rasilez (aliskiren; sold as Tekturna outside the USA), the first new type of high blood pressure medicine in more than a decade, and the diuretic hydrochlorothiazide in a single pill. The company’s Sandoz unit also received a positive opinion for filgrastim, a biosimilar of Amgen’s Neupogen, as a treatment for
neutropenia.
The CHMP also issued a positive opinion on Amgen’s Nplate (romiplostim) for the treatment of adult chronic immune idiopathic thrombocytopenic purpura, making it the 51st orphan medicine to receive the panel’s backing. The committee also looked favorably on Stelara (ustekinumab), from Janssen-Cilag for moderate-to-severe plaque psoriasis and Servier’s Valdoxan/Thymanax (agomelatine) for the treatment of
major depressive episodes in adults.
There was bad news for Bristol-Myers Squibb, however, as the CHMP rejected a marketing application for Ixempra (ixapebilone) for the treatment of metastatic or locally advanced breast cancer. The committee said that potential damage to nerve cells did not outweigh the “very small increase” in survival from breast cancer.
