UnaCom Product Development Round Up         

                                                      30th July- 5th August 

GSK on track for first paediatric treatment of severe asthma in Europe

The EMA has provided positive opinion on GSK's Nucala (Mepolizumab) as an add on treatment for severe refractory eosinophilic asthma in paediatric patients from the ages of 6-17. If approved it would be the first targeted biological therapy for the treatment of severe eosinophilic asthma in paediatric patients in Europe.

New Aegerion Treatment for Leptin Deficiency approved

The product Myalepta from Aegerion Pharmaceuticals has been approved by the European Commission to be a supplement for diet as a replacement therapy for the treatment of complications of leptin deficiency in lipodystrophy patients. This approval makes Myalepta the first and only licensed medication to treat the underlying deficiency at the heart of lipodystrophy. This is a massive step forward, providing a treatment for one of the most fundamental aspects of the condition.

Pfizer's new Ulcerative Colitis treatment and first oncological bio-similar approved by EMA 

The EMA have approved Pfizer's, Xeljanz for Ulcerative Colitis (UC) making it the first oral therapy and inhibitor to be approved for its patient population. Xelijanz has had two previous approvals for rheumatoid arthritis and psoriatic arthritis. Pfizer's, Trozimera has also been approved by the EC. It is an oncological drug and the first oncological bio-similar to be approved for Pfizer. It could have the potential to help patients with cancers such as breast and gastric. A bio-similar is a drug designed to have active properties similar to one that has been previously licensed.

Novartis gains approval for Europe's first Migraine Treatment

Novartis has had its new Aimovig drug (erenurmab) approved by the EMA, making it Europe's first treatment designed specifically to prevent migraines.

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