EMA Committee Offers Positive Opinion on New Drugs, Moves Forward with Key Concept Papers - - BioPharm International

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EMA Committee Offers Positive Opinion on New Drugs, Moves Forward with Key Concept Papers


BioPharm Bulletin

The latest meeting of EMA’s Committee for Medicinal Products for Human Use (CHMP) has concluded with more than 15 positive opinions for new and generic drugs. Among other important announcements, the agency released a range of concept papers and guidelines for consultation and announced a safety review of orlistat-containing medicines.

During the meeting, which took place Sept. 19-22, 2011, CHMP adopted several concept papers from various working groups. Each of the following noteworthy adopted papers was opened for a 3-month public consultation period: the Biologics Working Party’s concept paper for a guideline on the quality of porcine trypsin used in the manufacture of human biological medicinal products; the Vaccine Working Party’s concept paper on revising guidelines for influenza guidelines; and the Biosimilar Medicinal Product Working Party’s paper on revising the guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance. CHMP also adopted three new documents, two of which focused on guidelines for herbal medicines and one on revising an EMA clinical investigation guidance.

CHMP also offered several positive approvals for new drugs. One such authorization was for a novel antibiotic agent, which represents the first in a new class to treat infections with Clostridium difficile, a leading cause of disease in hospitals. Dificlir (fidaxomicin), developed by Optimer Pharmaceuticals and Astellas Pharma Europe, is a macrocyclic antibiotic with a new mode of treatment that reduces the chances of its activity being affected by resistance to other antibiotics. According to the EMA statement, the approval is a “major step forward by providing a new medicine to tackle the growing levels of resistance to available antibiotics.”

Positive opinions were also given for Novartis’s Rasitrio, for the treatment of essential hypertension, and Bristol-Myers Squibb and AstraZeneca EEIG’s Komboglyze, for the treatment of Type II diabetes mellitus. Gilead Sciences International and Janssen-Cilag International also received approval for their medicines (Eviplera and Edurant, respectively) aimed at treating HIV-1 infection. Several generic drugs were approved as well, including pioglitazone, used to treat Type II diabetes mellitus, and desloratadine, used to treat alletgic rhinitis and urticaria.

Finally, EMA began a review of orlistat-containing anti-obesity medicines to determine whether rare cases of hepatic injury will have any impact on the benefit-risk profile and conditions of use. The review will include the centrally authorized prescription-only medicine Xenical and the centrally authorized over-the-counter-medicine Alli, as well several other medicines containing orlistat that have either already or are in the process of being authorized at national level.

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