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EMA backs Pomalidomide Celgene in multiple myeloma

Further positive CHMP opinions for new medicines form Aegerion, Teva and more

EMA backs Pomalidomide Celgene in myelomaA recommendation for Celgene's pomalidomide in multiple myeloma was the headline announcement from the latest set of opinions from the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP).

The oral drug, to be marketed as Pomalidomide Celgene, received backing last week from the EU regulator for use in combination with the steroid dexamethasone to treat the bone marrow cancer.

The recommended use is limited to patients who have received at least two prior therapies, including both lenalidomide and bortezomib, and whose disease progressed after treatment with these medicines.

The EMA also emphasised the risk to pregnant women posed by pomalidomide, having a similar chemical structure to thalidomide, which led to the birth of babies with severe deformities during the 1950s and 1960s.

Because of this risk, Celgene will have to provide a programme to inform doctors and pharmacists about special measures to reduce the dangers of the drug, including a requirement for all women of child-bearing potential treated with Pomalidomide Celgene to undergo pregnancy tests and to use selected contraception.

Nevertheless, Pomalidomide Celgene will be a welcome new treatment for a condition that receives 27,800 diagnoses a year in Europe and has very limited treatment options for patients who relapse after initial therapy.

Despite its relative rareness, multiple myeloma is becoming an area of increasing interest for pharma companies, and Pomalidomide Celgene is one of two drugs approved by the US FDA in the past 12 months; the other being Kyprolis (carfilzomib) from Onyx Pharmaceuticals.

Other positive CHMP opinions
In addition to backing Celgene's pomalidomide, the CHMP also gave several other positive recommendations for new medicines.

These included Aegerion Pharmaceuticals Lojuxta (lomitapide) for the treatment of the genetic cholesterol condition homozygous familial hypercholesterolaemia. The recommendation is in addition to a low fat diet and other lipid-lowering medicinal product.

Elsewhere, there were further recommendations for Teva's (Lonquex) lipegfilgrastim, which was recommended for the reduction in white blood cells of cancer patients on chemotherapy; Bavarian Nordic's smallpox vaccine Imnavex; BioPartners's Somatropin as a replacement therapy for the endogeous growth hormone; and CLS Behring's human coagulation factor VIII Voncento for bleeding disorders.

3rd June 2013

From: Sales, Regulatory

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