Green light for new medicines

EMA Highlights by Gary Finnegan – The EMA’s Committee for Medicinal Products for Human Use (CHMP) has a new member: Ivana Mikacic has been nominated by Croatia which joined the European Union in July.

This brings the group’s total membership to 33. At its first meeting since Ms Mikacic joined the CHMP, several new medicines were approved. These include:

Giotrif, from Boehringer Ingelheim International GmbH. The drug will be licensed for treating epidermal-growth-factor-receptor (EGFR) tyrosine-kinase-inhibitor-naïve adult patients with locally advanced or metastatic non-small-cell lung cancer with activating EGFR mutations.

Incresync, Vipdomet and Vipidia – all from Takeda Pharma A/S – are to be granted marketing authorisations for the treatment of type-2 diabetes.

Ultibro Breezhaler and Xoterna Breezhaler, both from Novartis Europharma Ltd., were approved for the treatment of chronic obstructive pulmonary disease (COPD).

Grastofil, a biosimilar medicine from Apotex Europe BV, was approved for the treatment of neutropenia.

Tybost, from Gilead Sciences International Ltd., was approved as a pharmacokinetic enhancer of atazanavir 300mg once daily or darunavir 800mg once daily as part of antiretroviral combination therapy in HIV-1-infected adults.