Twelfth manufacturing approval for an innovator or New Chemical Entity drug and the company's fourth FDA accelerated approval
Ash Stevens (ASI), a leading provider of global contract pharmaceutical drug substance development and API manufacturing services, has received US FDA approval for its facility in Riverview, Michigan, to manufacture the API in ARIAD Pharmaceuticals’ recently approved oncology drug Iclusig (ponatinib).
The drug was granted accelerated approval on 14 December 2012 by the FDA for the treatment of adult patients with chronic, accelerated or blast phase chronic myeloid leukemia (CML) that is resistant or intolerant to prior tyrosine kinase inhibitor (TKI) therapy or Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) that is resistant or intolerant to prior TKI therapy.
Ponatinib is ASI's twelfth manufacturing approval for an innovator or NCE (New Chemical Entity) drug and the company's fourth FDA accelerated approval. The Pre-Approval Inspection (PAI) did not generate a FDA-483 citation and was a special achievement for Ash Stevens as it incorporated elements of Quality by Design (QbD). QbD is designed to yield more robust manufacturing processes than that which can be achieved by traditional approaches to drug development.
‘We are very proud to be ARIAD Pharmaceuticals' outsourcing partner for the development and manufacture of this important API,’ says Dr Stephen Munk, President and CEO of Ash Stevens. ‘We have a collaborative and highly productive relationship with ARIAD and we are excited to help provide this innovative therapy to cancer patients,’