The latest set of opinions from the European Medicines Agency’s Committee for Medicinal Products for Human Use include good news for Novartis, Eli Lilly and for three companies planning to launch a generic version of Sanofi-Aventis/Bristol-Myers Squibb’s blockbuster Plavix.


First up and Afinitor (everolimus), which Novartis believes will be a blockbuster, has been recommended as a treatment for patients with advanced renal cell carcinoma. The CHMP has also granted a positive opinion to Genzyme’s injectable Mozobil (plerixafor), intended for use in combination with granulocyte-colony stimulating factor in patients with non-Hodgkin's lymphoma and multiple myeloma undergoing stem cell transplantation.

The CHMP has also backed Samsca (tolvaptan), from Otsuka Pharmaceutical Co for the treatment of hyponatraemia secondary to syndrome of inappropriate antidiuretic hormone secretion. The drug was approved by regulators in the USA last week.

The EMEA’s advisors have also recommended that six generics of the bloodthinner Plavix (clopidogrel) can be sold in Europe. Four of the six are made by Switzerland’s Acino and partners, who already sell their copycat versions in Germany, with the other two manufactured by Teva Pharmaceutical Industries and Greek drugmaker Pharmathen.

On the negative side, the committee turned down Vedrop (tocofersolan), from Orphan Europe, a unit of Italy’s Recordati, intended for the treatment of vitamin E deficiency due to digestive malabsorption in children suffering from cholestasis.

The panel also recommended approval of Lilly’s Alimta (pemetrexed) to be extended to include monotherapy maintenance treatment for advanced non-small cell lung cancer. It is currently authorised as monotherapy for second-line treatment after prior chemotherapy, and as first line treatment in combination with cisplatin.


The committee concluded by saying that restrictions on Neupro (rotigotine), UCB’s transdermal patch for Parkinson’s disease and restless leg syndrome should be lifted.

A year ago supplies of the drug were limited to patients already on the medicine due to the discovery of crystallisation problems with the product, which is applied as a transdermal patch. The CHMP now says it is satisfied UCB had established a cold-chain supply system that meets quality standards.