Shire’s Vpriv recommended for European approval
pharmafile | June 28, 2010 | News story | Sales and Marketing | Brinavess, Gaucher, Rapiscan, Ruconest, Shire, Sycrest
Shire has won backing from a key European regulatory committee for its new Gaucher disease orphan drug.
Vpriv was one of five new treatments to be recommended for European approval by the EMA’s Committee for Medicinal Products for Human Use and received an accelerated assessment on public health grounds, due to the ongoing shortage of Genzyme’s Cerezyme.
Cerezyme is the only treatment for the disease currently approved, but its supply has been marred by contamination in the manufacturing process, for which Genzyme was recently fined.
The CHMP decided Vpriv might constitute an alternative treatment option for the condition.
President of Shire Human Genetic Therapies Sylvie Grégoire said: “A positive opinion for VPRIV in the EU, earlier than expected, is very good news, particularly as we have been working with physicians in 22 countries for almost a year to treat patients with type I Gaucher disease through early access programmes.
We look forward to our ongoing collaboration with these physicians and the Gaucher community at large as we enter the final stages of the approval process in Europe.”
Shire’s drug, which was approved by the FDA in February, is a human cell line derived enzyme replacement therapy (ERT) for the long-term treatment of type I Gaucher disease in both paediatric and adult patients.
Gaucher disease is a rare, inherited metabolic disorder in which harmful quantities of a fatty substance called glucocerebroside accumulate in the spleen, liver, lungs, bone marrow, and sometimes in the brain.
More new drugs recommended by CHMP
Alongside Vpriv, four other new medicines received positive opinion from the committee.
• Merck Sharp and Dohme’s Brinavess for atrial fibrillation
• Gilead’s Rapiscan, a stress agent used in heart scans to assess blood flow
• Ruconest from the Pharming Group, an orphan drug for angioedema attacks (a severe sudden swelling on the skin) using recombinant DNA technology
• Organon’s Sycrest, for the treatment of bipolar I disorder in adults.
Ben Adams
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