BRIEF—Negative opinions from EMA/CHMP

As well as recommending  seven medicines for approval at its January 2018 meeting, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) issued some negative opinions.

It made a negative recommendation on the extension of indication following re-examination of Santhera Pharmaceuticals’ (SIX: SANN) Raxone (idebenone),  as the company itself had said it expected just a day prior to the announcement.

The applicant for idebenone requested a re-examination of the Committee’s negative opinion for this medicine adopted at the September 2017 meeting. After considering the grounds for this request, the CHMP re-examined the opinion, and confirmed the refusal of the change to the marketing authorization.

The CHMP adopted a negative opinion for EnCyzix (enclomifene), from Renable Pharma. EnCyzix was expected to be used to treat hypogonadotrophic hypogonadism in men.