A Biotechnology company called BioMimetic Therapeutics Inc. announced that the Food and Drug Administration granted orphan drug status to its developing treatment for osteonecrosis of the jaw.
The drug candidate is eligible to receive seven years of marketing exclusivity, tax credits for clinical development costs, fee waivers and development assistance from the FDA.
Orphan drug status goes to drug candidates intended to treat conditions or diseases affecting fewer than 200,000 people. It is not clear yet how the FDA will respond when the affected patients go beyond the regulatory number.
Osteonecrosis of the jaw - also known as jaw rot and dead jaw disease - causes loosening of the teeth, pain, infection and soft-tissue swelling and massive jawbone destruction. The disease may be a problem for people on high doses of bisphosphonates such as Fosamax that are used to treat osteoporosis and other diseases.
Read the eMJA article.
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