- The committee responsible for advising the European Medicines Agency on what drugs to approve issued positive opinions on 10 medicines during its November meeting, which concluded Thursday.
- Included in the approval recommendations from the Committee for Medicinal Products for Human Use (CHMP) were Roche AG's multiple sclerosis drug Ocrevus, Amgen Inc. and Allergan plc's cancer biosimilar Mvasi, and AstraZeneca plc's eosinophilic asthma treatment Fasenra.
- Two orphan drugs — one for a rare disorder that inflames the esophagus, the other for prevention of cytomegalovirus reactivation and disease in patients who have undergone an allogeneic hematopoietic stem cell transplant — also received nods from the CHMP.
While the EMA doesn't have to follow CHMP recommendations, it usually does. And in that light, the committee's newest round of opinions could set up several drugmakers for big returns.
Roche, for instance, saw Ocrevus sales of CHF 308 million (about $310 million) during the third quarter. The Swiss pharma noted during its most recent earnings call that it was "fully on track" for the drug's launch in the European Union. Ocrevus, the first treatment approved for the primary progressive form of multiple sclerosis, has had strong uptake in the U.S., and Roche is hoping a similar rollout will take place across the Atlantic.
A good way to consider Ocrevus' uptake in Europe would be to "look at the uptake of new MS medicines in these different countries that have launched in the past versus how they have launched in the U.S.," Roche CEO Daniel O'Day said on the call. "I wouldn’t expect necessarily a grossly different dynamic there because I think the same type of restrictions that may have existed for other MS therapies could apply to Ocrevus and the uptake as well."
Biosimilar competition to Roche's MabThera (rituximab) has also crimped the company's bottom lines in Europe. An EMA thumbs up for Ocrevus could help offset those declines.
Speaking of biosimilars, an Mvasi (bevacizumab-awwb) approval would be welcome news for Amgen and Allergan. The drug, which mirrors Roche's Avastin (bevacizumab), recently became the first copycat biologic to a cancer therapy to receive an all-clear from the Food and Drug Administration.
Biosimilars haven't gained much traction in the U.S. due to legal hurdles. They're more established in Europe, however, which may lend itself to quicker returns on Mvasi.
Also among the 10 drugs to get positive CHMP opinions in November were two generic versions of darunavir, the active ingredient in Johnson & Johnson's HIV medication Prezista. Worldwide sales of Prezista/Prezcobix/Rezolsta totaled $467 million during the third quarter.