Novartis Receives FDA Therapeutic Breakthrough Status for Ligelizumab – Green Share | 01/14/21

Novartis achieved an important partial success with its product candidate ligelizumab (QGE031) in the USA.

The health authority FDA has given the drug for the treatment of hives (chronic spontaneous urticaria; CSU) the status of “therapy breakthrough”, as Novartis announced on Thursday.

The agent may be used in patients who suffer from urticaria, but respond only inadequately to H1 antihistamine therapy. According to Novartis, CSU is an unpredictable and serious skin disease. It is characterized by the development of itchy, painful wheals (hives), swelling (angioedema), or both, which last for at least 6 weeks and occur for no known cause.

The FDA grants breakthrough therapy status to therapies that target a serious or life-threatening disease and that have potentially significant improvement over existing therapies in one or more significant clinical endpoints.

For the Novartis share in Swiss trading it is currently 0.46 percent high to 83.48 francs.

Basel (awp)