La Jolla Pharmaceutical Company Receives Orphan Designation from FDA for LJPC-0118

La Jolla Pharmaceutical (NASDAQ:LJPC) has announced that the US Food and Drug Administration (FDA) has granted the company orphan drug designation for its investigational drug product, LJPC-0229 to treat malaria.

As quoted in the press release:

“The granting of orphan drug status is a significant milestone for the LJPC-0118 program and highlights the significant unmet medical need for the treatment of malaria,” said George Tidmarsh, M.D., Ph.D., La Jolla’s President and Chief Executive Officer. “There are currently no approved treatments in the U.S. for patients with severe malaria. We are preparing to file a new drug application later this year and, upon approval, to making this front-line treatment for severe malaria available to the public.”

The FDA Orphan Drug Designation Program provides orphan status to drugs and biologics which are defined as those intended for the safe and effective treatment, diagnosis or prevention of rare diseases/disorders that affect fewer than 200,000 people in the U.S. Orphan Drug Designation conveys up to seven years of marketing exclusivity if the sponsor is the first to obtain regulatory approval from the FDA and offers various development incentives, including tax credits related to clinical trial expenses, an exemption from the FDA-user fee and FDA assistance in clinical trial design. The Orphan Drug Designation does not change the standards for approval.

Click here to read the full press release.