Regrow Biosciences has announced a breakthrough achievement of getting a US FDA nod for conducting a phase-II trial of Ossgrow, an orphan drug that helps in treating Osteonecrosis, in the US market. The company moves one-step closer to attain a global market monopoly estimated at $5 billion through this feat, a company statement notified.
Regrow Biosciences has been granted Orphan Drug Designation (ODD) for Ossgrow from the US FDA and the European Medicines Agency (EMA). Furthermore, after completing phase-III clinical trials in India, Ossgrow received marketing authorisation from the Indian FDA (DCGI) in 2017. The product has successfully treated more than 1,000 patients across 200 hospitals, the statement added.
Osteonecrosis, mainly seen in the hip joint, is a progressive bone disease that leads to the death of bone tissue due to interrupted blood supply. The initial stages are asymptomatic; however, the disease progresses rapidly, affecting the structure and eventually the function of the joint. The advanced stage involves the collapse of the femoral head and arthritis. This necessitates the patients who are barely in their 30s and 40s to undergo hip replacement surgery causing severe loss of productivity and decreased quality of life, the statement concluded.