Xechem's SCS drug cleared in Nigeria

New Jersey, USA-based Xechem International says that its Nigerian subsidiary has received approval from the domestic regulatory authority, the National Agency for Food and Drug Administration and Control, for Nicosan, its proprietary herbal agent for the prophylactic management of sickle cell disease.

The approval is for an initial term of two years, which will allow Xechem to complete confirmatory Phase III clinical trials in Nigeria but the firm noted that, despite this, it faces no marketing and sale restrictions in the country.

According to Xechem, Nicosan is an anti-sickling natural herbal drug developed by Nigerian scientists at the National Institute for Pharmaceutical R&D. In clinical studies conducted by the NIPRD, the drug substantially reduced the degree of sickling of the red blood cells of SCD sufferers. Xechem noted that clinical trials so far have shown that the large majority of patients on Nicosan no longer experience sickle cell crises and, even when they are not eliminated, their number and severity are substantially reduced.