Looks like Novartis AG—the Switzerland-based drug maker—will have to put an unforeseen hold on plans to replenish its drug range. On Friday the company suffered a setback as the European advisory panel commented that it would not recommend Novartis’ serelaxin treatment for acute heart failure.
The company has now said that it plans to request the committee of the European Medicines Agency to reconsider and re-examine the drug. With this, Novartis expects to receive a conditional approval to enter the market with its product. Novartis can, for now, launch the drug in the European market even as the drug’s late-stage trial continues to take place simultaneously.
David Epstein, who heads Novartis Pharmaceuticals, stated that the company now plans to file a whole new package so as to support the approval application for the drug over the next few weeks. According to Epstein, the company expects to hear of a positive opinion as early as the second quarter of the year.
Novartis has been relying on new products such as its serelaxin drug to reload its product portfolio in the global market. Some of its drugs are on the verge of losing patent protection and thus, they will soon be in neck to neck competition with generic drugs. As this happens, Novartis will find the competition cutting into its drug revenue.
According to Epstein, the company regards serelaxin as a drug that could potentially prove to be a blockbuster drug, with the ability to bring in annual revenue to the tune of USD 1 billion.
Serelaxin is a drug that works by relaxing blood vessels as it is a form of human hormone. It has been formulated for use as heart failure treatment. Heart failure is a condition wherein the heart is unable to pump enough quantities of blood. Currently, though heart failure is a widespread condition, no treatments are available for the same.
Currently, Novartis is conducting a second Phase 3 drug trial. This is the last stage of testing the drug on humans before it can be submitted to agencies for an approval. The intermediate results of the trial are expected by 2015.