Friday, July 26, 2013

Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 22-25 July 2013 - Eight new medicines recommended for approval

The CHMP recommended the approval of Boehringer Ingelheim's Giotrif (afatinib) for the treatment EGFR +ver NSCLC. The drug would compete with Roche's Tarceva,

The CHMP also recommended approval for Takeda's Incresync (alogliptin/pioglitazone), Vipdomet (alogliptin+metformin) and Vipidia (Alogliptin)  for the treatment of type 2 diabetes.

Novartis got a  nod for its LABA/LAMA FDC - Ultibro Breezhaler (glycopyrronium bromide, indacaterol or QVA149) for the treatment of COPD.
The Committee recommended that Tybost should be granted a marketing authorisation for the treatment of human immunodeficiency virus-1 (HIV-1) infection in combination with protease inhibitors atazanavir and darunavir.
The Committee also gave a positive recommendation for the approval of Apotex's Grastofil, a biosimilar medicine for the treatment of neutropenia.
Negative opinion for Delamanid
The Committee adopted a negative opinion for Delamanid which was intended for the treatment of multi-drug resistant tuberculosis.
Seven recommendations on extensions of therapeutic indications
The CHMP recommended extensions to the existing indications for Eylea, Ilaris, Prezista, Revolade (thrombocytopenia associated with chronic hepatitis C infection) , Simponi (Ulcerative collitis) and Stelara (Psoriatic arthrtis).
Re-examination of two initial recommendations for marketing authorisation
The CHMP adopted a positive re-examination opinion for Defitelio, for the treatment of severe hepatic veno-occlusive disease (VOD) in patients undergoing blood stem-cell transplantation.
It also adopted a final negative opinion following the re-examination of Xeljanz which was intended for the treatment of moderate to severe active rheumatoid arthritis.

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