Nycomed and AstraZeneca are the chief beneficiaries of the latest recommendations issued by the advisors to the European Medicines Agency.

First up, the Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion on Nycomed’s Daxas (roflumilast) for maintenance treatment of severe chronic obstructive pulmonary disease as an add-on to a bronchodilator. The recommendation is a boost for the Swiss firm, coming as it does a couple of weeks after advisors to the US Food and Drug Administration voted against recommending approval of Daxas, an oral once-daily phosphodiesterase 4 enzyme inhibitor.

This morning, Nycomed has received a further boost with the signing of a co-marketing deal with Merck & Co for Daxas in certain European countries and Canada (in the UK, Merck will have exclusive commercialisation rights to the COPD drug). Financial details have not been disclosed.

The Committee also backed AstraZeneca’s Seroquel XR (quetiapine) as an add-on for major depressive disorder. That decision comes after regulators in the Netherlands, acting as the reference member state for the European Union's mutual recognition process, rejected the MDD application for the antipsychotic in May, questioning the risk-benefit profile.

Following the Dutch decision, AstraZeneca went straight to the CHMP, thus seeking a central approval. The latter has now completed its review and “concluded that the benefit-risk profile of this medicine was positive”.

The European regulator added that it has been told by Genzyme Corp that supply shortages for the firm’s Gaucher disease drug Cerezyme (imiglucerase) and Fabry disease drug Fabrazyme (agalsidase beta) are continuing, following the well-documented problems at a manufacturing facility in the USA. These are likely to continue until the end of September.

The CHMP has also decided that products for topical use containing bufexamac, a non-steroidal anti-inflammatory drug, should have their marketing authorisations revoked.