MSN Laboratories Gets CDSCO Panel Nod To Manufacture, Market Selexipag for Injection
New Delhi: The drug major MSN Laboratories has got a go-ahead from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) to manufacture and market Selexipag for injection 1800 mcg/vial (Lyophilized powder for injection) for the treatment of Pulmonary Arterial Hypertension (PAH).
However, this approval is subject to the condition that the applied drug product i.e. Selexipag for injection 1800 mcg/vial (Lyophilized powder for injection) should be used only in patients who are already under treatment with Selexipag tablets, but temporarily unable to take oral therapy due to any serious condition or stage of hospitalization. Further, the condition stated that this should be highlighted in the package insert.
In addition, the expert panel highlighted that the drug product permission and prescribing Information should include the following “warning”:
“To be sold by retail on the prescription of a Cardiologist/Pulmonologist only”
This came after MSN Laboratories presented the proposal of manufacture and marketing permission of Selexipag for injection 1800 mcg/vial (Lyophilized powder for injection) for already approved indication along with therapeutic rationale and justification for clinical trial and bioavailability/Bioequivalence (BA/BE) waiver, before the committee.
Selexipag is in a class of medications called selective non-prostanoid prostacyclin receptor agonists. Selexipag is indicated for the treatment of pulmonary arterial hypertension (PAH, WHO Group I) to delay disease progression and reduce the risk of hospitalization for PAH.
Pulmonary arterial hypertension (PAH) is one form of a broader condition known as pulmonary hypertension, which is high blood pressure in the lungs. In PAH, this increased pressure in the vessels is caused by an obstruction in the small arteries in the lung for a variety of reasons.
Selexipag acts as an agonist of the prostacyclin receptor to increase vasodilation in pulmonary circulation and decrease elevated pressure in the blood vessels supplying blood to the lungs.
At the recent SEC meeting for Pulmonary held on 5th July 2023, the expert panel reviewed the proposal presented by MSN Laboratories to manufacture and market Selexipag for injection 1800 mcg/vial (Lyophilized powder for injection) for already approved indication along with therapeutic rationale and justification for clinical trial and BA/BE waiver.
The committee observed that Pulmonary Arterial Hypertension (PAH) is a serious, life-threatening, rare disease, for which there is an unmet medical need in the country. Selexipag is already approved in USA, EU and designated as an orphan drug. Further, Selexipag tablets 200mcg/400mcg/600mcg/800mcg/1000m cg/1200mcg/1400mcg/1600mcg are already approved in India.
After detailed deliberation, the committee considered clinical trial and BA/BE waiver for the applied drug product and recommended the grant of permission to manufacture and market Selexipag for injection 1800 mcg/vial (Lyophilized powder for injection) for already approved indication subject to conditions as mentioned below:
1. The applied drug product i.e. Selexipag for injection 1800 mcg/vial (Lyophilized powder for injection) should be used only in patients who are already under treatment with Selexipag tablets, but temporarily unable to take oral therapy due to any serious condition or stage of hospitalization. This should be highlighted in the package insert.
2. The firm should conduct a Phase-IV clinical trial of the drug product. Accordingly, the firm should submit Phase-IV clinical trial protocol within six months from the date of approval of the drug product to CDSCO for further review by the committee.
3. The drug product permission and prescribing Information should include the following “warning”: “To be sold by retail on the prescription of a Cardiologist /Pulmonologist only”
4. Use of this injectable “only in cases who are already on this drug in tablet form” should be highlighted.
Also Read:Novartis gets CDSCO Panel Nod To Import, Market Inclisiran solution for injection
