From their meeting in February, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has published the highlights.After a scintillating FIFTEEN medicine approvals in January, this month only sees two recommended approvals, including one new and one generic medicine.
The Committee has recommended granting a marketing authorisation for Fetcroja (cefiderocol), which is to be used for the treatment of aerobic Gram-negative bacterial infections in adults with limited treatment options. The generic medicine Tigecycline Accord has also received a positive opinion for complicated skin, soft tissue and intra-abdominal infections.
The CHMP have made three recommendations on extending therapeutic indications for Alunbrig, Ofev and Otezla. Entyvio has received a recommendation for the addition of a new pharmaceutical form. There has been one negative opinion for an extension of indication for Emgality. Applications to extend the use of Axumin, Opdivo and Yervoy were withdrawn.
Additionally, the CHMP have commenced a review of Yondelis for the treatment of ovarian cancer and soft tissue carcinoma. A clinical study (OVC-3006) investigating this medicine was stopped early as interim analysis of the results showed that patients did not live significantly longer when given Yondelis.
An Indian Clinical Research Organisation (CRO) is also under review, after a good clinical practice inspection (GCP) raised concerns about the pharmacokinetic bioequivalence study data being too similar to have occurred by chance.
A detailed report of the outcomes of the meeting can be found here.