International Approvals: Nicosan/Hemoxin, Vigil, IPM Wound Gel
http://www.medscape.com/viewarticle/515428 Oct. 25, 2005 — The European Medicine Evaluation Agency has approved orphan drug status for the phytomedicine niprisan in the treatment of sickle cell disease; Germany's Federal Institute for Drugs and Devices has approved modafinil tablets for the treatment of moderate to severe chronic shift work sleep disorder; and Costa Rica's Ministry of Health has approved a hyaluronic acid–based gel for the management of exuding or debrided wounds.
Orphan Drug Niprisan (Nicosan/Hemoxin) for Sickle Cell Disease in EU
On Oct. 4, the European Medicine Evaluation Agency (EMEA) approved orphan drug status for the phytomedicine niprisan (Nicosan/Hemoxin, made by Xechem International, Inc.) for the treatment of sickle cell disease (SCD).
Niprisan is an ethanol/water extract of Piper guineenses seeds, Pterocapus osum stem, Eugenia caryophyllum fruit, and Sorghum bicolor leaves.
The approval was based in part on data from a phase 2b, placebo-controlled, double-blind crossover study in 82 Nigerian patients. The data showed that treatment with niprisan significantly reduced the frequency of SCD crises associated with severe pain during a six-month period (P < .01). Moreover, 73% of patients achieved complete remission.
Niprisan did not appear to cause acute hepatic toxicity, as assessed by liver enzyme activity; evaluation of serum creatinine and blood urea nitrogen levels suggested that renal function also remained normal. No serious adverse events were reported.
Niprisan (Hemoxin) was previously granted orphan drug status for this indication by the U.S. Food and Drug Administration in August 2003.
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