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news.US-based pharmaceutical firm Medac Pharma has received approval from the US Food and Drug Administration (FDA) for the name Rasuvo for its lead compound, MPI-2505, a subcutaneous injectable methotrexate (MTX) delivered in a ready-to-use autopen.
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Rasuvo, which is currently under FDA review, is being developed for multiple indications, including rheumatoid arthritis (RA), poly-articular-course juvenile RA and psoriasis.
The drug is designed to improve bioavailability and overcome tolerability issues associated with today’s oral MTX therapies.
The company intends to provide Rasuvo in ten dosage strengths, ranging from 7.5mg to 30mg in 2.5mg increments.
Medac Pharma president and CEO Terri Shoemaker said securing name approval for the company’s lead compound is another important milestone as the company prepares for a potential US launch of Rasuvo later in 2014.
"With its planned 10 dosage strengths and ease of administration, Rasuvo is well-positioned to offer patients an optimal therapeutic option for managing rheumatoid arthritis and other related diseases as our product will offer the widest range of dosing options compared to other subcutaneous methotrexate therapies," Shoemaker said.