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Home Industry News Shire receives CHMP backing for approval of Onivyde

Shire receives CHMP backing for approval of Onivyde

25th July 2016

Shire's new pancreatic cancer therapy Onivyde has been recommended for European regulatory approval by the Committee for Medicinal Products for Human Use (CHMP).

The European Medicines Agency committee has adopted a positive opinion recommending the authorisation of Onivyde for the treatment of metastatic adenocarcinoma of the pancreas in combination with 5-fluorouracil and leucovorin.

Onivyde is intended for adult patients whose disease has progressed following gemcitabine-based therapy. The recommendation is based on data from the phase III NAPOLI-1 trial, which showed the survival benefits associated with the drug.

Shire is responsible for the development and commercialisation of Onivyde outside the US and Taiwan under an exclusive licensing agreement with Merrimack Pharmaceuticals.

Dr Philip Vickers, head of research and development at Shire, said: "There has been little improvement in the prognosis for patients with metastatic pancreatic cancer in over 20 years. We therefore welcome the CHMP positive opinion for Onivyde."

Earlier this month, Shire launched a paediatric indication for HyQvia, the subcutaneous immunoglobulin treatment for primary and certain secondary immunodeficiencies it recently acquired as part of its takeover of Baxalta.ADNFCR-8000103-ID-801822355-ADNFCR

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