Bivalirudin RTU Injection is indicated for use as an anticoagulant in patients undergoing percutaneous coronary intervention (PCI), including patients with heparin-induced thrombocytopenia and heparin-induced thrombocytopenia and thrombosis syndromeGland Pharma Ltd along with its partners MAIA Pharmaceuticals Inc and Athenex Pharmaceutical Division on Monday announced the launch of a Ready-to-Use Bivalirudin Injection in the US. This is the first on-frozen ready-to-use bivalirudin 505b(2) NDA approved by the U.S
Food and Drug Administration (USFDA), a press release from Gland Pharma said.
Bivalirudin RTU Injection is indicated for use as an anticoagulant in patients undergoing percutaneous coronary intervention (PCI), including patients with heparin-induced thrombocytopenia and heparin-induced thrombocytopenia and thrombosis syndrome.
"We are pleased to collaborate with MAIA and Athenex in bringing to market the RTU non-Frozen Version of Bivalirudin Injection. We believe that this complements our commitment to provide Easy to Use, Safe to Deliver, Cost Effective Products to clinicians," Srinivas Sadu, MD and CEO of Gland Pharma said.Ulinastatin is a “well-researched, fairly old drug”, available in the country since 2012 and manufactured by few companies including BSV. Around one million vials have been used in the country. The company’s brand, U-TRYP had sales of Rs 24 crore for the 12-month period ended April. The price of a vial is around Rs 1500 each, with the therapy expected to cost around Rs 30,000-50,000 per patient for a protocol of minimum seven days.
“There’s a good chance of the drug working on hospitalised Covid-19 patients who have breathlessness,” he said, adding the company has done seven trials in India for other indications. Ulinastatin is manufactured at the company’s facility in Thane (Maharashtra).
The mortality risk is higher when an individual with Covid-19 infection develops ARDS and pneumonia. ARDS causes dry cough, heavy breathing, breathing difficulties and increased heart rate. Ulinastatin, in such cases, can be used as a remedy to combat the underlying inflammatory condition related to ARDS in Covid-19 patients.
Meta-analysis of over 2,300 ARDS patients globally treated with Ulinastatin has shown significant improvement in oxygenation index, shortening duration of mechanical ventilation, reduced mortality and ICU stay as compared to conventional therapies, the company said.
The Rs 1,000-crore portfolio of BSV includes drugs for hormones, monoclonals, equine human serums and plasma derivatives. It is one of the major products of Japan-based Mochida Pharmaceuticals, and is also manufactured in China and Korea.