Celgene ($CELG) has received the stamp of approval from the European Commission for its oral medication pomalidomide, in combination with the steroid dexamethasone, for the treatment of relapsed and refractory multiple myeloma in patients who have received previous therapies.
The approval adds to a growing numbers of meds that are being developed to combat the blood cancer, in which plasma cells--responsible for making antibodies that help fight infections--replicate uncontrollably and build up in the bone marrow.
The decision follows a positive opinion issued by Europe's Committee for Medicinal Products for Human Use (CHMP) in May. Approval was based on the results from a Phase III trial of 455 patients, in which patients treated with pomalidomide plus low-dose dexamethasone had prolonged survival.
Celgene, which markets Revlimid and other drugs for myeloma, said in a statement that it plans to launch the drug in the EU under the name Imnovid after submitting a regulatory notification to the European Medicines Agency to change the trade name. In February, the FDA approved the oral med, branded as Pomalyst in the U.S.
Last month, Celgene spent $100 million to gain an exclusive option to buy Acetylon Pharmaceuticals. It was a strategic move for Celgene, with Boston-based Acetylon's most advanced drug candidate in a Phase Ib clinical trial for multiple myeloma. Celgene is riding a wave of success lately, also reporting in July that sales were up 13% for the second quarter to $1.05 billion. Last quarter it reported 16.5% growth in sales of the breakthrough blood cancer drug and raised its earnings forecast for the year after beating analysts' projections.
European regulators have also approved Lonquex lipegfilgrastim from Teva Pharmaceutical Industries ($TEVA) to prevent chemotherapy-induced neutropenia, the condition of having a low count of certain white blood cells needed to guard against infections. Teva gained Lonquex through its 2010 acquisition of ratiopharm GmbH.
- here's the release