Three medicines recommended for approval
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended three medicines for approval at its April 2018 meeting.
The CHMP recommended granting a marketing authorisation for Biktarvy (bictegravir / emtricitabine / tenofovir alafenamide), for the treatment of HIV-1 infection.
One hybrid medicine, Dzuveo (sufentanil) received a positive opinion for the treatment of pain. Hybrid applications rely in part on the results of pre-clinical tests and clinical trials for a reference product and in part on new data.
The Committee recommended for approval the generic medicine Carmustine Obvius (carmustine), for the treatment brain tumours, non-Hodgkin’s lymphoma and Hodgkin’s disease.
Start of re-examination of recommendations on new medicines
The applicants for Dexxience (betrixaban) and Eladynos (abaloparatide) have requested re-examinations of the CHMP’s negative opinions for these medicines adopted at the March 2018 meeting.
The applicant for Alsitek (masitinib) has also requested a re-examination of the Committee’s negative opinion for this medicine, which was adopted via written procedure on 18 April 2018.
The CHMP will now re-examine these opinions and issue final recommendations.
Eight recommendations on extensions of therapeutic indication
The Committee recommended extensions of indications for Cimzia, Perjeta, Prolia, Sprycel, Tagrisso, Xeljanz, Xultophy and Yervoy.
Withdrawals of applications
The application for an initial marketing authorisation for Prohippur (sodium benzoate) was withdrawn. This medicine was intended to be used for the treatment of non-ketotic hyperglycinaemia and urea cycle disorders.
An application to extend the use of Qtern (saxagliptin / dapagliflozin) in patients with type 2 diabetes has also been withdrawn.