New Delhi: British-Swedish multinational drugmaker, AstraZeneca’s stride to win approval from the Indian drug regulators for the additional indications of its drug Dapagliflozin in worsening heart failure and nephropathy in the strength of 5mg and 10mg has been rejected by the Central Drugs Standard Control Organization (CDSCO) Committee.
The SEC Committee declining the nod asked the firm to submit the regulatory approval status from other countries.
Dapagliflozin, sold under the brand name Farxiga among others, is a medication used to treat type 2 diabetes. It is from the gliflozin class. It was developed by Bristol-Myers Squibb in partnership with AstraZeneca.
In India, the drug is also sold by top pharma giants including Abbott and Sun Pharmaceutical Ltd who sell it under the brand names Gledepa 10 mg Tab and Oxra 10 mg Tab respectively.
Dapagliflozin has been introduced as anti-diabetic medication. It works by removing excess sugar from your body through urine.
Recently, AstraZeneca has proposed to the regulators in India for Dapagliflozin film-coated tablet in the strength of 5mg and 10mg for additional indication including the prevention of new or worsening heart failure or cardiovascular death and the prevention of new or worsening nephropathy.
However, the committee noted that the proposal of the firm for the additional indication is not yet approved in any country. Also, there is no data for 5mg strength of the drug or Fixed Dose Combination (FDC) with Metformin for the said claims.
After detailed deliberation, the SEC committee of CDSCO rejected the proposal recommending that the firm should submit the regulatory approval status from other countries and revise their proposal in respect of the strength of the drug and FDCs and indication in line with the outcomes of the study.
The firm’s current proposal for additional indication is based on the outcome of a global clinical trial study (A Phase IIIb, multicentre, randomised, double-blind, placebo-controlled trial to evaluate the effect of Dapagliflozin 10mg once daily on the Incidence of Cardiovascular death, Myocardial Infarction, or Ischemic stroke in patients with type 2 Diabetes (DECLARED1693C00001) conducted by AstraZeneca, in which India was one of the participating countries with 193 Indian patients.
Prior to this, in 2012, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency issued a positive opinion on the drug.
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MD Team 
Subject Expert Committee (SEC) depends upon the foreign regulatory data especially a drug which was approved based on the GCT data.