Novartis International AG is pharmaceutical company based in Basel, Switzerland. Novartis invests billions of dollars, annually for development of news drugs. Some program are successful and some don’t. Two of the drugs that were being developed by Novartis received a red signal. Novartis announced that it is stopping further development of two investigational compounds (drugs), Albinterferon alfa-2b for adults with chronic hepatitis C and Mycograb (efungumab) an antifungal agent for invasive candidiasis in adults.
Why is Novartis cancelling development of announced drugs?
Albinterferon alfa-2b, the hepatitis compound was being developed jointly with Human Genome Sciences Inc. Novartis received “complete response letter” from Food and Drug administration, which is request for more information. Novartis felt that its current dose will, more than likely, nit get FDA approval. It expected similar response from European Union. This drug was named as Zalbin in the US and Joulferon in European Union.
Another drug was an antifungal agent, Mycograb (efungumab) was intended to be used in combination with amphotericin B for candidiasis in adults –...
a common yeast infection. European Medicines Agency refused to grant marketing authorization for Mycograb to Novartis on two separate occasions. The agency was concerned about the quality and safety issues related to the drug.
This is the first time a pharmaceutical company has cancelled its drug program owing to non approval from regulatory agencies. This decision will cost Novartis 590 million dollars. Novartis is a pharma giant and has backbone to absorb this loss. I am sure it will bounce back with a break through drug either from its research or through acquisition.
Source: Medical News Today