Dr. Roddy's gets CDSCO panel nod to manufacture & market Treprostinil solution for Infusion
New Delhi: Granting a local clinical trial waiver, the Subject Expert Committee (SEC) of the Central Drugs Standard Control Organization (CDSCO) has given its nod to pharmaceutical major Dr. Reddy's Laboratories to manufacture and market prostacyclin vasodilator Treprostinil solution for Infusion (1.0 mg/ml, 2.5 mg/ml, 5.0 mg/ml, 10.0 mg/ml) for the treatment of pulmonary arterial hypertension.
This came in line with the proposal presented by the pharma major Dr. Reddy's Laboratories for manufacturing & marketing Treprostinil solution for Infusion (1.0 mg/ml, 2.5 mg/ml, 5.0 mg/ml, 10.0 mg/ml) along with justification for a local clinical trial waiver before the committee.
Treprostinil is a synthetic analogue of prostacyclin, used to treat pulmonary hypertension.
Pulmonary arterial hypertension (PAH) is a disease in which blood pressure is abnormally high in the arteries between the heart and lungs. PAH is characterized by symptoms of shortness of breath during physical exertion. The condition can ultimately lead to heart failure.
Treprostinil is a potent oral antiplatelet agent. The major pharmacologic actions of treprostinil are direct vasodilation of pulmonary and systemic arterial vascular beds and inhibition of platelet aggregation. It helps to improve symptoms such as shortness of breath and tiredness. It works by relaxing and widening the blood vessels (arteries) in the lungs and other parts of the body so that blood can flow more easily.
It is administered by continuous subcutaneous or intravenous infusion. Due to the risks associated with chronic indwelling central venous catheters including serious bloodstream infections, subcutaneous infusion (undiluted) is the preferred mode of administration and continuous intravenous infusion should be reserved for patients stabilized with treprostinil subcutaneous infusion and who become intolerant of the subcutaneous route, and in whom these risks are considered acceptable.
At the recent SEC meeting for cardiovascular and renal dated 08.03.2022, in response to the drug major Dr. Reddy's Laboratories proposal, the committee noted that the drug is already approved in countries like the US, EU, Canada & Japan, and also drug is designated as orphan drug and indicated for serious and life-threatening disorder and there is an unmet medical need in the country.
After detailed deliberation, the committee recommended the grant of permission to manufacture and marketing of Treprostinil solution for Infusion (1.0 mg/ml, 2.5 mg/ml, 5.0 mg/ml, 10.0 mg/ml).
