The US Food and Drug Administration’s decision on Avandia, GlaxoSmithKline’s $3 billion drug to fight Type-2 diabetes will have far-reaching implications.
HYDERABAD: The US Food and Drug Administration’s (FDA) decision on Avandia, GlaxoSmithKline’s $3 billion drug to fight Type-2 diabetes, on Monday, will have far-reaching implications for pharma firms including Dr Reddy’s Laboratories.
The possible FDA verdicts range from Avandia’s withdrawal from the market to its restricted availability with stringent health warnings.
The decision is important for Dr Reddy’s, which is planning to launch its own own Type-2 diabetes molecule in about 18 months.
Avandia came under the spotlight on May 21 when Steven E Nissen, chairman of cardiovascular medicine at the Cleveland Clinic in the US, wrote in an article in the New England Journal of Medicine that the drug increased the risk of heart attacks in patients by 43%.
The analysis sparked off a major controversy bring the entire class of drugs that fight Type-2 diabetes - called ‘thiazolidinediones’ — under the lens, apart from raising doubts over the functioning of the FDA itself.
The other drugs in this class include ‘poiglitazone’, manufactured by Japanese giant Takeda Pharmaceuticals and sold under the brand name Actos, and ‘troglitazone’ the drug made by Parke-Davis/Warner Lambert and sold under the brand name Rezulin.
Rezulin was pulled out of the market in March 2000 because it caused liver toxicity.
Dr Reddy’s molecule, which the company calls ‘balaglitazone’, is being developed in association with Rhoescience A/s, a Denmark-based biopharmaceutical company.
The drug is currently under Phase III clinical trials in Europe. The FDA may impose labeling restrictions apart from additional testing if Avandia is to be allowed on the market.
These are the two issues which will affect the value of balaglitazone, G V Prasad, Dr Reddy’s vice chairman, told DNA Money recently.
The company is keenly watching the proceedings and is in touch with the FDA on the matter, he added.
“Our differentiating focus is that balaglitazone will have less side affects, less addition to less weight gain,” he said, adding that the company would take the R&D on the molecule to its logical conclusion no matter what the US decision is.
“Balaglitazone will have to compete with Avandia and Actos in Europe whatever be the outcome in the US,” Prasad stressed.
Avandia in any case is sold with restrictions in Europe with the European Medicines Agency taking action late last year by strengthening warnings on the medicine.
The drug is contraindicated in patients with heart failure anyway and the packing contains warnings about Ischemia (a condition where blood flow, and therefore oxygen, is restricted to a part of the body), too.
Prasad felt the FDA would not be more stringent this.
Avandia is GSK’s second largest selling drug after asthma drug Adavir. But sales of the drug fell 22% to $708 million in the June quarter following the meta analysis though the company mounted a robust defence.
However, sales in Europe went up 20% to $122 million during the quarter with the research failing to have any impact, the company said. Sales in international markets fell 9%.
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