FDA approves easy-to-use injectable methotrexate for RA, psoriasis, juvenile arthritis
EWING, N.J. — The Food and Drug Administration has approved a new drug made by Antares Pharma for treating rheumatoid arthritis and psoriasis, the drug maker said Monday.
Antares announced the approval of Otrexup, a version of the common arthritis drug methotrexate — commonly referred to as MTX — that is designed for once-weekly injection underneath the skin by the patient and marketed in an easy-to-use, disposable automatic injection device. The drug is meant for adults with severe RA who have had inadequate responses to full-dose non-steroidal anti-inflammatory drugs, children with polyarticular juvenile idiopathic arthritis, or pJIA, and adults with psoriasis.
"This new delivery system for methotrexate provides a welcome option for physicians and their patients to continue effective use of methotrexate," University of Colorado School of Medicine medical professor Michael Schiff said. "Otrexup can be used when a response is inadequate or there are tolerability issues with oral methotrexate, before adding or switching to costlier therapies."
SPAARx establishes Metro D.C. office
ARLINGTON, Va. — A specialty pharmacy industry group has established new offices near the nation’s capital.
The Specialty Pharmacy Association of America announced the new offices are located in Arlington, Va. SPAARx’s new office will open on Tuesday in the Ballston area of the city.
"Having already addressed critical issues facing specialty pharmacy stakeholders, such as HI-TECH legislation and other regulatory concerns, SPAARx looks forward to further advancing its current dialogues and establishing new relationships in a collaborative manner with the variety of pharmacy organizations and others in the metro D.C. area," SPAARx COO Kevin Alder said. "SPAARx will continue to work in advocating and advancing the knowledge and understanding of specialty pharmacies and its role in providing patient access to needed treatments and quality to both the legislative and regulatory decision makers."
Auxilium, Vivus in deal worth up to $300 million for erectile dysfunction drug
CHESTERBROOK, Pa. — Auxilium Pharmaceuticals will have exclusive rights to market a drug for erectile dysfunction in the United States and Canada, under a new licensing agreement with the drug’s manufacturer.
Auxilium announced the deal with Vivus for Stendra (avail). Under the license, Auxilium will pay Vivus a one-time license fee of $30 million. If the Food and Drug Administration approves a change to the drug’s label to reflect an onset of the drug’s effecting 15 minutes or less, Auxilium will pay a $15 million milestone payment, as well as royalties and up to $255 million in potential milestone payments based on various sales goals.
"We believe Stendra complements our current portfolio of testosterone replacement therapy and [erectile dysfunction] products, further broadening our men’s healthcare franchise in a very large market segment consisting of patients that tend to switch among products," Auxilium president and CEO Adrian Adams said. "We believe the unique features of Stendra, including its dosing interval [of] 30 minutes prior to sexual activity, ability to take with or without food, modest alcohol consumption requirements and a favorable side effect profile make it an exciting entrant into the category."