EMA committee recommends five drugs for approval
pharmafile | March 30, 2015 | News story | Sales and Marketing | Boehringer, CHMP, EMA, Eisai, Europe, Gardasil, Lenvima, Merck, akynzio, jardiance, lilly
Cancer and diabetes treatments are among those given the go ahead in the latest round of approvals by the EMA.
The European regulator’s Committee for Medicinal Products for Human Use (CHMP) recommended five drugs during its March meeting.
After a review under the EMA’s accelerated assessment programme, Eisai’s Lenvima (lenvatinib) earned a thumbs up for the treatment of adults with progressive, locally advanced or metastatic differentiated thyroid carcinoma, whose disease has progressed despite receiving radioactive iodine.
It comes just weeks after Lenvima was approved in the US by the FDA and shortly after the US became the first country where Eisai launched the drug. The EMA’s accelerated assessment programme cuts the average approval time from 210 to 150 days.
The Committee also recommended Merck’s Gardasil 9, a human papillomavirus (HPV) vaccine that protects against certain diseases caused by nine different strains of the HPV virus. This is five more than the Gardasil vaccine that is used in the national NHS cervical cancer vaccination programme in England.
Boehringer and Lilly gained a nod for diabetes drug Synjardy, which combines Jardiance (empagliflozin) with the generic diabetes treatment metformin, for adults with type 2 diabetes that is not controlled with other medications. The companies say that the new treatment, if signed-off by the European Commission, will be marketed as Synjardy in Europe by the two companies through their diabetes alliance.
This month the CHMP also recommended the approval of Akynzeo (netupitant/palonosetron), for the prevention of chemotherapy-induced nausea and vomiting, and the generic medicine Voriconazole Hospira, as a branded alternative to voriconazole for the treatment of fungal infections. The committee also put forward an extension of the indication for the influenza antiviral Tamiflu to include the treatment of infants under one years old.
Lilian Anekwe
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