EMA – media

EMA, MHRA to review Vertex’ Kaftrio for children with CF

The European Medicines Agency (EMA) and the Medicines and Healthcare products Regulatory Agency (MHRA) have validated Vertex’ applications to expand the scope of its cystic fibrosis (CF) treatment Kaftrio (ivacaftor/tezacaftor/elexacaftor). The drugmaker is seeking approval for the drug’s use in combination with ivacaftor in patients ages six years and older who have at least one F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene. If approved, this will extend the indication for the triple combination therapy to children ages six through 11 years old in EU countries, Great Britain and Northern Ireland. In children with CF, symptoms and organ damage including lung disease manifest very early in life. “We are committed to working diligently with global regulators to expand the indication for our medicine such that younger people living with CF will also be able to access the triple combination therapy,” said Nia Tatsis, executive VP, chief regulatory ...
- Source: drugdu
- 618
- May 21, 2021
EMA
EMA accepts MAA for romosozumab in the treatment of osteoporosis

The EMA has accepted the Marketing Authorization Application for romosozumab in the treatment of osteoporosis in postmenopausal women and in men at increased risk of fracture.
- Source: europeanpharmaceuticalreview
- 910
- February 2, 2018
Amgen EMA Evenity (romosozumab) osteoporosis romosozumab
Seven medicines leap closer to EU approval

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has put forward seven new medicines for approval in the region, including new treatment options for haemophilia A, diabetes, and a very rare genetic disorder.
- Source: pharmatimes
- 1,022
- January 30, 2018
CHMP diabetes EMA haemophilia A Hemlibra polices Roche
Trillion in search of new partners

Trillium Therapeutics is seeking new partners as it looks over its pipeline with an eye to the future.
- Source: fiercebiotech
- 781
- July 5, 2017
EMA EU Market Views
MPs keen for close collaboration with EMA post Brexit

British MPs say they are keen to secure a close working relationship with the European Union on drug regulation post Brexit to protect patient health and investment in the UK’s life sciences sector.
- Source: pharmatimes
- 874
- July 4, 2017
Company Insight EMA EU

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