CDSCO rejects Cipla’s application for marketing US-based MannKind Corporation’s inhaled insulin, branded Afrezza; Local climical trial is compulsory

• An expert panel of the Central Drugs Standard Control Organisation (CDSCO) has insisted that a local clinical trial should be compulsorily conducted before marketing human insulin inhalation powder, a rapid-acting inhaled drug for glycemic control in adult diabetes patients, in the Indian market.
• A proposal by pharmaceutical major Cipla Limited to sell the drug on the basis of clinical data generated in the US has been denied by the regulator’s subject expert committee (SEC) for endocrinology and metabolism.

Last year, Cipla had entered into an exclusive distribution agreement with US-based MannKind Corporation for marketing the latter’s inhaled insulin, branded Afrezza, in India. The drug is the only US Food and Drug Administration-approved inhaled insulin available for patients suffering from diabetes. Under the agreement, Cipla will be responsible for obtaining regulatory approvals to distribute Afrezza in the domestic market, including clearance from the Drug Controller General of India (DCGI).

The US FDA approved the first inhaled insulin, Pfizer’s Exubera, way back in 2006. But the drug maker later stopped manufacturing it as it was finding few takers. There were also concerns among clinicians that the drug might cause lung problems.

Afrezza is a rapid-acting inhaled insulin that is also FDA-approved for use before meals. It must be used in combination with long-acting insulin in patients with type 1 diabetes and should not be used by those who smoke or have chronic lung disease.