(CELG - Free Report
) announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has rendered a positive opinion for its phosphodiesterase 4 (PDE4) inhibitor, Otezla. The CHMP has issued a positive opinion on the drug for the treatment of moderate-to-severe chronic plaque psoriasis in adults who failed to respond to or, who have a contraindication to, or are intolerant to other systemic therapy including cyclosporine, methotrexate or psoralen, and ultraviolet-A light (PUVA).
The CHMP also recommended the approval of Otezla for the treatment of active psoriatic arthritis in adult patients who have had an inadequate response or who have been intolerant to a prior disease modifying antirheumatic drug (DMARD) therapy – either as a monotherapy or in combination with DMARDs.
The positive CHMP opinion was based on encouraging data from two phase III programs, PALACE and ESTEEM. The European Commission is expected to render a final decision on Otezla in the next two to three months.
We note that Otezla is already approved by the FDA for the treatment of adult patients with active psoriatic arthritis (Mar 2014) and for the treatment of patients with moderate-to-severe plaque psoriasis who are candidates for phototherapy or systemic therapy (Sep 2014). We believe that Otezla has a high chance of gaining approval in the EU following the positive recommendation from the CHMP.
Celgene carries a Zacks Rank #2 (Buy). Other well-ranked stocks in the health care sector include AMAG Pharmaceuticals, Inc. (AMAG - Free Report
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) and Actavis (ACT - Free Report
) . While AMAG Pharma carries a Zacks Rank #1 (Strong Buy), Bristol-Myers and Actavis carry the same rank as Celgene.