FDA grants marketing approval for Shire's Vpriv

FDA has granted marketing approval for Shire's Vpriv, a human cell line derived enzyme replacement t

Shire said that Vpriv offers patients and their physicians a new treatment option at a critical time, as the supply of the previously approved ERT for gaucher disease is uncertain and remains disrupted.

With FDA approval of Vpriv, Shire has implemented enhancements to its existing OnePathSM Access Program with the introduction of a new Co-Pay Assistance Program.

Shire said that the new program was developed based on feedback from the rare disease community. It is designed to simplify the process and paperwork associated with initiation of therapy, and to reduce the financial burden for patients who are treated with Shire HGT therapies in the US, including Vpriv. The company has also announced that it will price Vpriv at a 15 per cent savings over the other commercially available ERT for Gaucher disease.

Through this program, Shire HGT plans to cover these patients' insurance co-pay for the first 3 months of their therapy in 2010. In 2011, the company intends to cap eligible patients' out of pocket prescription expenses at $500.

Rhonda Buyers, CEO and executive director of national gaucher foundation (NGF), said: "The last 6 months have been very challenging for the entire Gaucher community, and the approval of Vpriv brings an important new treatment option to patients suffering from Type 1 Gaucher disease.

"We at the NGF are excited about this approval, and by the steps that Shire has taken to improve access to treatments for patients with life-altering conditions. This co-pay program will greatly assist the Gaucher patient population, and we appreciate the fact that Shire has taken the time to listen to us and to act on the needs of patients."