Cipla Gets CDSCO Panel Nod To import, market Human Insulin inhalation powder with inhaler
New Delhi: Pharmaceutical major Cipla has got a go-ahead from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to import and market Human insulin inhalation powder with inhaler [Technosphere insulin 4U/ 8U/ 12U] for the indication “to improve glycemic control in adult patients with diabetes mellitus".
However, the nod is subject to the condition that the firm should conduct an active post-marketing surveillance study (PMS) in the country.
This came after the drug maker Cipla presented the results of Phase III clinical trial conducted in India for the drug product Human insulin inhalation powder with inhaler [Technosphere insulin 4U/ 8U/ 12U for seeking approval to import and market the drug product for the indication “to improve glycemic control in adult patients with diabetes mellitus".
Insulin human inhaled is a man-made insulin that is breathed in through the lungs and is used to control high blood sugar in patients with diabetes. Insulin is one of many hormones that help the body turn food into energy. This is done by using the glucose (sugar) in the blood as quick energy.
Inhaled insulin treats diabetes by increasing your body's insulin levels. This medication comes in an inhaler. You can breathe in this insulin before a meal as directed. A healthcare provider will give you instructions on how to take and adjust each dose based on your activities.
Technosphere Insulin (TI) is a novel inhalation powder for the treatment of diabetes mellitus. Technosphere Insulin delivers insulin with an ultra-rapid pharmacokinetic profile that is distinctly different from all other insulin products but similar to natural insulin release. Such rapid absorption is often associated with penetration enhancers that disrupt cellular integrity.
The Technosphere technology platform is based on Technosphere particles, which are formed by the self-assembly of crystals of fumaryl diketopiperazine (FDKP), a proprietary novel excipient. Technosphere Insulin powder consists of insulin that is adsorbed to Technosphere particles with a size range appropriate for the delivery of drugs to the deep lung.
Technosphere Insulin has been shown to deliver insulin to the bloodstream with a pharmacokinetic profile characterized by a rapid rise in plasma insulin concentration that is much faster than subcutaneous insulin injection.
At the recent SEC meeting for Endocrinology and Metabolism held on 7th March 2024, the expert panel reviewed the results of Phase III clinical trial conducted in India for the drug product Human insulin inhalation powder with inhaler [Technosphere insulin 4U/ 8U/ 12U for seeking approval to import and market the drug product for the indication “to improve glycemic control in adult patients with diabetes mellitus".
After detailed deliberation, the committee recommended the grant of permission to import and market Human insulin inhalation powder with inhaler [Technosphere insulin 4U/ 8U/ 12U] subject to the condition that the firm should conduct an active PMS study in the country.
In accordance with the above, the expert panel suggested that the firm should submit the active PMS study protocol to CDSCO within three months of the grant of marketing authorization.
