» » Shire Receives Positive Opinion From CHMP For Type 1 Gaucher Disease Therapy – Update

Shire Receives Positive Opinion From CHMP For Type 1 Gaucher Disease Therapy – Update

(RTTNews) – Biopharmaceutical company Shire plc (SHPGY, SHP.L) said Friday that the Committee for Medicinal Products for Human Use of the European Medicines Agency adopted a positive opinion on the marketing authorization for VPRIV, the company’s enzyme replacement therapy to treat type 1 Gaucher disease.

Dublin, Ireland-based Shire said the opinion of the Committee for Medicinal Products for Human Use or CHMP will be forwarded to the European Commission for ratification, to help bring a new Gaucher treatment to market in all EU Member States. The therapy was previously approved by the U.S. Food and Drug Administration on February 26.

In addition to the CHMP positive opinion, VPRIV has received orphan drug designation from the Committee for Orphan Medical Products.

Gaucher disease, a rare and often debilitating condition, is the most prevalent of the lysosomal storage disorders and has classically been categorized into 3 clinical types. Type 1 Gaucher disease is characterized by variability in signs, symptoms, severity, and progression. Type 1 is the most common and is distinguished from type 2 and type 3 by the lack of early neurological symptoms.

VPRIV or velaglucerase alfa is made using the company’s gene-activation technology in a human cell line. The drug produces glucocerebrosidase enzyme, which has the exact human amino acid sequence and has a human glycosylation pattern.

With the accelerated adoption of VPRIV worldwide and the earlier than anticipated US approval and EU positive opinion, Shire expects continued high demand for the therapy. In line with the expected rise in demand, the company has started implementing a program with physicians and patients to manage requests from new patients in order to ensure long-term, uninterrupted treatment.

SHP is currently trading on the London Stock Exchange at 1,416.00 pence per share, up 3.00 pence or 0.21%, on a volume of 1.227 million shares.

SHPGY is currently trading on the Nasdaq at $63.60, up $0.14 or 0.22%, on a volume of 0.24 million shares.

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