Glenmark gets CDSCO panel nod to import, market Akynzeo
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 Glenmark to import and market Akynzeo, a fixed-dose combination drug for the prevention of chemotherapy-induced nausea and vomiting.
However, the approval is conditional on the company conducting a Phase-IV clinical trial and submitting the protocol within 3 months of approval of the drug for review by the committee.
This came in the wake of the proposal presented by drug-maker Glenmark Pharmaceuticals for import and marketing of the drug Fosnetupitant and Palonosetron 235 mg/0.25 mg concentrate for solution for infusion (Akynzeo IV) along with CT waiver before the committee.
Fosnetupitant is a medication used in combination with others to prevent chemotherapy-associated nausea and vomiting.
Palonosetron is a serotonin antagonist used in the prophylaxis or management of vomiting that results from emetogenic chemotherapy, and for the management of postoperative nausea and vomiting.Palonosetron is an antagonist of 5-HT3 receptors that is indicated for the prevention and treatment of chemotherapy-induced nausea and vomiting.
In April 2018, the U.S. Food and Drug Administration (FDA) and the Swiss company Helsinn approved the intravenous formulation of AKYNZEO as an alternative treatment option for patients experiencing chemotherapy-induced nausea and vomiting.
Earlier, the Medical Dialogues Team had reported that Glenmark Pharmaceuticals had launched Akynzeo in India and Nepal under an exclusive licencing pact with Swiss pharma group, Helsinn.
The committee, at its 113th SEC meeting for Oncology & Hematology, has thoroughly examined the drug-maker Glenmark Pharmaceutical's proposal for the import and marketing of the drug Fosnetupitant and Palonosetron 235 mg/0.25 mg concentrate for solution for infusion (Akynzeo IV) along with the CT waiver before the committee.
The committee observed that the drug is intended for use in patients who are not able to take oral anti-emetic medicines, and that this is an unmet medical need for the drug in the country.
After detailed deliberation, the committee recommended the grant of permission to import and market the drug with a local clinical trial waiver for the indication as approved in the USA, subject to the condition that the firm conduct a Phase-IV clinical trial for which protocol should be submitted within 3 months of the approval of the drug for review by the committee.
In addition to this, the committee also directed that the drug be sold at retail only under the prescription of an oncologist.
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