Someone in Europe isn't too happy that Orexigen's (NASDAQ: OREX) obesity drug, Mysimba, got a positive recommendation from the Committee for Medicinal Products for Human Use, or CHMP. The drug, which goes by the name Contrave in the U.S., will be reviewed in a meeting by the European Commission, or EC, next month.
In the standard European drug approval process, after the European Medicines Agency's CHMP issues its recommendation, the EC reviews the opinion and makes a final decision on the marketing authorization after about three months. Typically, the EC decision is done by written vote, but member states can ask for a meeting to review the CHMP decision, which is what has happened here. Orexigen didn't say which country made the request, but David Lyons of Ireland and Joseph Emmerich of France were the only two votes against the approval, so it's likely one of them.
Rubber stamp
In the U.S., advisory committees made up of outside experts make approval recommendations to the FDA, but the agency has the final say. There are many examples of companies getting positive recommendations from committees only to be rejected by the FDA, including Orexigen's first attempt at an approval in the U.S.
In the EU, the situation is completely different. Technically, the CHMP makes "recommendations" to the EC, but the CHMP is more akin to the FDA than a committee of outside experts. In fact, the people voting on the CHMP recommendations are regulators from each of the member states.
I only know of two cases where the CHMP made a positive recommendation and the EC didn't eventually approve. Both had extenuating circumstances.
After Johnson & Johnson's Zeftera was given a positive recommendation by the CHMP in 2008, the committee learned that the FDA was concerned about the study sites that performed the clinical trial used to support the approval. The committee eventually determined that the trial results may not be reliable because the study wasn't performed under "good clinical practice" at some of the sites, and it eventually reneged its positive recommendation.
Last year, Merck and Endocyte got a positive opinion from the CHMP for their cancer drug vintafolide based on phase 2 data, but two months later, the duo stopped the phase 3 confirmation trial early because patients getting the drug weren't doing any better than those who got a placebo. The companies subsequently withdrew the EU marketing application.
EU important for Orexigen
The request for a meeting to review Mysimba seems more political than anything else. Last month, a coalition of European consumer groups called the European Bureau of Consumer Unions wrote to the EC asking the commission to not approve Mysimba. Prescrire, a non-profit continuing education organization, also complained about the approval.
While the meeting vote introduces some uncertainty to the eventual approval, it still seems very likely the EC will give Mysimba a full approval. The drug only needs a simple majority to gain final EC approval, and 31 out of 33 CHMP members voted in favor of the positive recommendation.
The EU is important for Orexigen because Mysimba is the only new oral drug up for approval. Both Arena Pharmaceuticals' Belviq and VIVUS' Qsymia failed to gain CHMP backing, leaving the EU market wide open. Novo Nordisk's Saxenda was recently given a positive CHMP opinion, but it has to be injected.
Europe is also an important market because Orexigen still owns the entire rights to the drug there; it only gets a royalty in the U.S. from its partner Takeda Pharmaceuticals. The biotech has said it plans to license the EU rights as well, which should garner Orexigen some up-front cash.
