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Review of the new drugs authorized in 2015

  • 28 January 2016
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Now is the time to take a look at the new drugs authorized in 2015 by the EMA (European Medicines Agency) and by the FDA (U.S. Food and Drug Administration).

In 2015, the EMA (European Medicines Agency) has positively evaluated 39 new compounds.

Names like Blincyto, Farydak, Imlygic, Opdivo, Entresto, Repatha, Praxbind and Wakix, identify some of these new drugs, which are now starting to be commercialized.

There is no doubt regarding the area of greatest interest: one third of the new drugs are for the treatment of cancer.

An increase has been observed in the development of drugs for rare diseases. Last year drugs for the treatment of non-24 hour sleep-wake disorder in completely blind adults, lysosomal acid lipase deficiency and pediatric-onset hypophosphatasia were approved.

On the other hand, the FDA has approved 45 new molecules and 3 new biomolecules. This year has seen the approval of the greatest historic number of new drugs for the treatment of rare diseases.

These new drugs have been put on the market and now is the time to monitor their benefits and risks for the patients. This means that the work of the EMA and the FDA does not end when these new drugs are approved, but continues after they are put on the market.

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Review of the new drugs authorized in 2015Review of the new drugs authorized in 2015