MassHighTech December 2, 2003

 

Anika Therapeutics gets preliminary OK from FDA for osteoarthritis treatment

Woburn-based Anika Therapeutics Inc. has received a preliminary approval from the U.S. Food and Drug Administration (FDA) for its pre-market approval application (PMA) for its osteoarthritis treatment Orthovisc.

Orthovisc is a highly purified, high molecular weight form of hyaluronic acid for treating patients suffering from osteoarthritis of the knee.

In a letter, the FDA states that an approval order will be issued subject to a successful inspection of Anika's manufacturing facility.

"This achievement marks a significant milestone for Anika Therapeutics and we are pleased with the outcome of the FDA's review of our PMA application thus far," said Charles H. Sherwood, chief executive of Anika, in a statement. "One of our top corporate priorities is to now focus on securing an agreement with a strategic U.S. partner who will lead the commercialization efforts for Orthovisc."

Designed to relieve pain and stiffness and improve joint mobility, Orthovisc has been marketed internationally since 1996, and currently is sold in Canada and various European and Middle Eastern nations.

Anika Therapeutics stock opened at $9.74, up 72 cents from yesterday’s close.