Trade Resources Industry Views Medac Pharma Has Reported FDA Acceptance of a NDA for Its Lead Product Candidate

Medac Pharma Has Reported FDA Acceptance of a NDA for Its Lead Product Candidate

Tags: FDA, MTX, NDA, MPI-2505

US-based Medac Pharma has reported the US Food and Drug Administration (FDA) acceptance of a new drug application (NDA) for its lead product candidate, MPI-2505, a subcutaneous injectable methotrexate (MTX) in a ready-to-use injection device, for which the proposed indications are rheumatoid arthritis (RA), poly-articular-course juvenile RA and psoriasis.

Simultaneously, Medac Pharma's parent company medac announced the allowance of a US patent application directed to a method for the treatment of inflammatory autoimmune diseases by subcutaneously administering MTX at a concentration of more than 30mg/ml.

The company said that the subcutaneous mode of delivery of MPI-2505, with a wide range of dosing options, has been designed to improve bioavailability and overcome tolerability issues related with the existing oral MTX therapies.

In addition, by providing patients with a ready-to-use autopen and concentrated formulations that allow for reduced drug volume, the MTX subcutaneous autopen addresses the stigmas associated with injectable medicines.

Medac Pharma president and CEO Terri Shoemaker said the FDA's acceptance of the NDA marks a significant milestone not only for the company, but also patients seeking a more personalized method for managing their disease.

"While methotrexate has proven itself as a highly effective medicine for treating several forms of arthritis, there remains a substantial need to make treatment for this patient demographic more manageable," Shoemaker added.

"As a newly-founded company, we believe this inflection point, combined with our patent allowance for a broad dosing range of methotrexate, serve as stepping stones for our commitment to providing valuable resources for the immunology market."

The company intends to self commercialize its subcutaneous MTX autopen device in the US later in 2014, subject to the FDA approval.

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Medac Gets Fda Acceptance of New Drug Application for Mpi-2505