Justify bioequivalent data: CDSCO Panel Tells Sun Pharma on Mirabegron Extended-release Tablets
New Delhi: After reviewing the bioequivalence (BE) report of Mirabegron extended-release Tablets 50 mg presented by drug major Sun Pharma, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has opined the firm to justify the product is bioequivalent with the reference product.
This came after the drug major Sun Pharma proposed manufacturing and marketing permission for Mirabegron extended release Tablets 25 mg and 50 mg and presented the BE report of Mirabegron extended-release Tablets 50mg for which permission has been taken from the BA/BE Export Division before the committee.
Mirabegron is a beta-3 adrenergic agonist used to treat overactive bladder and neurogenic detrusor overactivity. Mirabegron has been shown to have a high safety and efficacy profile by large random placebo-controlled clinical trials. Mirabegron is used to treat urgency, urge urinary incontinence, and increased urinary frequency found in the overactive bladder.
Mirabegron is a medication used in the management of overactive bladder. It is in the sympathomimetic class of medications. It received approval from the US Food and Drug Administration (FDA) in June 2012 for treating overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency.
Mirabegron is a potent and selective agonist of beta-3 adrenergic receptors. The activation of beta-3 receptors relaxes detrusor smooth muscle during the storage phase of the urinary bladder fill-void cycle, which increases the bladder's storage capacity thereby alleviating feelings of urgency and frequency.
At the recent SEC meeting for Urology held on 20th February 2024, the expert panel reviewed the proposal presented by the drug major Sun Pharma to manufacture and market permission for Mirabegron extended-release Tablets 25 mg and 50 mg.
After detailed deliberation, the committee noted that the firm submitted a 90% Confidence Interval of AUC (0-72) and AUC (0-infinity) was found to be 97.30 to 119.84 and 97.63 to 138.80 respectively against the acceptance limit within 80-125%.
In light of the above, the expert panel suggested that the firm may submit a justification to prove that the product is bioequivalent to the Reference product.
Accordingly, the committee stated that the firm should submit additional data to CDSCO for further review by the committee.
