FDA Clears Self-Injectable Formulation of BMS’ Rheumatoid Arthritis Drug

FDA approved a subcutaneous formulation of Bristol-Myers Squibb’s fusion protein drug Orencia® (abatacept) for the treatment of adults with moderate-to-severe rheumatoid arthritis (RA). The drug is indicated for use,  either as monotherapy or in combination with disease-modifying antirheumatic drugs (except TNF antagonists or anakinra), for reducing signs and symptoms of RA, including major clinical response, inhibiting the progression of structural damage, and improving physical function.

BMS says Orencia is the only biologic for treating RA that has been approved both in an intravenous infusion formulation and as a self-injectable subcutaneous formulation. The drug will be commercially available in the U.S. in September. The self-injectable Orencia formulation is designed to be administered once-weekly, following a single IV loading dose, although the IV loading dose can be omitted in patients who are unable to receive the infusion.

FDA clearance of subcutaneous Orencia was based on data from four clinical trials in nearly 2,000 patients, including a Phase III comparative registrational study, Acquire, in 1,457 patients. Acquire compared therapy using Orencia SC plus methotrexate with Orencia IV plus methotrexate in terms of ACR 20 response at six months.

Most of the enrolled patients with moderate-to-severe active RA had demonstrated an inadequate response to methotrexate monotherapy. Comparable ACR 20 response rates of 76% were seen in both groups at month six. ACR 50 and ACR 70 response rates were also comparable between patients receiving Orencia SC and IV, as were improvements in all patient-reported outcomes studied.

The IV formulation of Orencia is available in major markets worldwide for the treatment of adult and/or juvenile patients with moderate-to-severe active RA. The drug achieved worldwide sales of $228 million in the second quarter of 2011 (ending June 30), up 28% on the equivalent 2010 period. Worldwide sales for the six months up to June 30, 2011, were $427 million, up 23%.