AstraZeneca’s T2D med Qtrilmet OK’d in Europe

The European Commission has approved AstraZeneca’s (NYSE:AZN) Qtrilmet (metformin hydrochloride saxagliptin and dapagliflozin) modified-release tablets to improve glycemic control in adults with type 2 diabetes (T2D).

It was approved in the U.S. in May under the brand name Qternment XR.

https://seekingalpha.com/news/3519679-astrazenecas-t2d-med-qtrilmet-okd-europe

European advisory group backs Jazz Pharma’s solriamfetol

The European Medicines Agency’s advisory group CHMP has adopted a positive opinion recommending approval of Jazz Pharmaceuticals’ (NASDAQ:JAZZ) solriamfetol to improve wakefulness and reduce excessive daytime sleepiness (EDS) in adults with narcolepsy (with or without cataplexy) or obstructive sleep apnea (OSA) whose EDS has not been satisfactorily treated by primary OSA therapy, such as continuous positive airway pressure.

Solriamfetol is a dual-acting dopamine and norepinephrine reuptake inhibitor.

A final decision from the European Commission usually takes ~60 days.

https://seekingalpha.com/news/3519693-european-advisory-group-backs-jazz-pharmas-solriamfetol

European advisory group backs Novartis’ Isturisa and Mayzent

The European Medicines Agency’s advisory group CHMP has adopted a positive opinion recommending approval of Novartis’ (NYSE:NVS) Isturisa (osilodrostat) for the treatment of Cushing’s syndrome, a metabolic disorder in which the body produces excessive amounts of the hormone cortisol.

CHMP also backs Mayzent (siponimod) for the treatment of adults with secondary progressive multiple sclerosis with active disease.

A final decision from the European Commission usually takes ~60 days.

https://seekingalpha.com/news/3519697-european-advisory-group-backs-novartis-isturisa-mayzent

European advisory group backs Roche’s Polivy for DLBCL

The European Medicines Agency’s advisory group CHMP has adopted a positive opinion recommending conditional approval of Roche’s (OTCQX:RHHBY) Polivy (polatuzumab vedotin), an antibody-drug conjugate, for the treatment of relapsed/refractory diffuse large B-cell lymphoma (DLBCL), in combination with Rituxan (rituximab) and chemo agent bendamustine.

A final decision from the European Commission usually takes ~60 days.

https://seekingalpha.com/news/3519698-european-advisory-group-backs-roches-polivy-dlbcl

Rigel Pharma up on CHMP nod for Tavlesse

It took an extra month, but the European Medicines Agency’s advisory group CHMP has adopted a positive opinion recommending approval of Rigel Pharmaceuticals’ (NASDAQ:RIGL) Tavlesse (fostamatinib) for the treatment of primary thrombocytopenia (low blood platelets) in adult patients who have not responded to other treatments.

In October, CHMP indicated a “positive trend vote.”

https://seekingalpha.com/news/3519701-rigel-pharma-10-percent-premarket-chmp-nod-tavlesse

European advisory group backs Mylan’s generic DuoPlavin

The European Medicines Agency’s advisory group CHMP has adopted a positive opinion recommending approval of Mylan N.V.’s (NASDAQ:MYL) clopidogrel/acetylsalicylic acid, a generic version of Sanofi’s (NASDAQ:SNY) heart med DuoPlavin.

A final decision from the European Commission usually takes ~60 days.

https://seekingalpha.com/news/3519703-european-advisory-group-backs-mylans-generic-duoplavin

European advisory group backs expanded use of Roche’s Kadcyla

The European Medicines Agency’s advisory group CHMP has adopted a positive opinion backing the use of Roche’s (OTCQX:RHHBY) Kadcyla (trastuzumab emtansine) as monotherapy for the adjuvant treatment of adult patients with HER2-positive early breast cancer who have residual disease in the breast and/or lymph nodes after neoadjuvant taxane-based and HER2-targeted therapy.

Kadcyla is currently approved in the EU for adult patients with HER2-positive, unresectable locally advanced or metastatic breast cancer who previously received trastuzumab and a taxane, separately or in combination.

A final decision usually takes ~60 days.

https://seekingalpha.com/news/3519709-european-advisory-group-backs-expanded-use-roches-kadcyla