EMA greenlights 15 new meds

The CHMP recommended granting marketing authorisations for two hybrid medicines: Budesonide/Formoterol (fumarate dihydrate) from Teva Pharma B.V. for the treatment of asthma and chronic obstructive pulmonary disease; and Trepulmix (treprostinil sodium), for the treatment of chronic thromboembolic pulmonary hypertension. Hybrid applications rely in part on the results of pre-clinical tests and clinical trials of an already authorised reference product and in part on new data.

The Committee recommended six extensions of indication for Biofrontera Bioscience GmbH’s Ameluz, Roche’s MabThera, Janssen-Cilag International NV Rezolsta, Sanofi’s Suliqua, Gilead Sciences Ireland UC Tybost and AbbVie Deutschland GmbH & Co. KG’s Venclyxto.

Celgene Europe B.V. withdrew its December application for an initial marketing authorisation for the AML cell therapy candidate Idhifa (enasidenib) after the EMA had mentioned concerns about the medicine’s risk/benefit ration.

MSD also withdrew its application to extend the use of its PD-L1 blocker Keytruda (pembrolizumab) in the treatment of cancer of the oesophagus after the agency considered that the results from the pivotal clinical study did not show that Keytruda was effective at prolonging the lives of patients with cancer of the oesophagus.