EMA backs approval of key drugs from Celgene and Aegerion

Two drugmakers reported regulatory victories for therapies in the important European market. A European Medicines Agency committee endorsed approval of Celgene's ($CELG) pomalidomide for multiple myeloma and Aegerion's ($AEGR) Lojuxta for a genetic cause of high cholesterol called homozygous familial hypercholesterolemia.

The European Commission is expected to decide on whether to green-light drugs for the EU market in the coming months, following the FDA approvals of Lojuxta in December and pomalidomide (Pomalyst) in February. The commission often does, but isn't obligated to, take the recommendations of the EMA's Committee for Medicinal Products for Human Use (CHMP).

Cambridge, MA-based Aegerion said it expects to learn of the EC's decision on approval of Lojuxta in the third quarter, with commercial rollouts planned on a country-by-country basis. The company has a crosstown rivalry going with Genzyme, the Cambridge unit of Sanofi ($SNY), which offers the competing therapy mipomersen (Kynamro) that the FDA approved in January.

Celgene has previous experience in multiple myeloma, a cancer of the plasma cells, with its blockbuster Revlimid and Thalomid. The biotech powerhouse relies heavily on Revlimid for revenue, and pomalidomide is among a slate of new drugs expected to provide business growth in the coming years. The CHMP backed requested approval of the oral drug in combination with dexamethasone for use in myeloma patients who had previously taken Revlimid and Takeda's Velcade.

Summit, NJ-based Celgene expects to learn of the European Commission decision on pomalidomide in two to three months. The company aims to offer three oral therapies for patients with myeloma, giving the company an edge in an increasingly competitive market for drugs against the blood cancer.

- see Celgene's release
- here's Aegerion's release
- and Reuters' article

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