EMA backs approval of Revestive, Zinforo and Seebri Breezhaler, but not Elelyso; Hexaxim opinion

Following meetings last week, the European Medicines Agency issued a number of recommendations and opinions regarding marketing authorization applications from Nycomed, AstraZeneca, Novartis, Pfizer and Sanofi Pasteur.

First, the EMA on Friday recommended approval of Revestive (teduglutide), from Nycomed, a subsidiary of Japan’s Takeda (TYO: 4502) for the treatment of adult patients with short bowel syndrome. This is the first medical treatment recommended for approval in Europe in this rare but seriously debilitating condition.

Revestive was designated as an orphan medicine in 2001. The Agency gave free scientific advice to the applicant during the development of the medicine. Orphan designation and the associated incentives such as free scientific advice or 'protocol assistance' are among the Agency's most important instruments to encourage the development of medicines for patients suffering from rare diseases. In clinical trials, Revestive has demonstrated that it can additionally reduce parenteral nutrition requirements in patients with short bowel syndrome.