EMA recommends seven medicines for approval after September meeting
Following its latest meeting, the EMA's CHMP has suggested granting marketing authorisation to seven medicines and extending the indications of 15 others.
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Following its latest meeting, the EMA's CHMP has suggested granting marketing authorisation to seven medicines and extending the indications of 15 others.
REGN-COV2 will be evaluated alongside standard-of-care in a Phase III study as part of the COVID-19 RECOVERY trial.
Dexamethasone Taw will be examined by the EMA on an accelerated assessment timetable, to assess whether it should be given to patients with COVID-19.
Researchers have shown that symptoms in patients experiencing severe COVID-19 improved when given either sarilumab or tocilizumab, interleukin-6 inhibitors.
The EMA has begun to review dexamethasone to provide an opinion on the results of the RECOVERY study for the treatment of adults admitted to hospital with COVID-19.
Dapivirine Vaginal Ring (dapivirine) and Blenrep (belantamab mafodotin) have been recommended for approval by the EMA's CHMP, along with nine other medicines.
The portfolio will be offered to low- and lower-middle-income countries to help financially strained healthcare systems care for COVID-19 patients.
The UK government has approved dexamethasone to be available on the NHS, following clinical trials proving its efficacy at reducing the risk of death for COVID-19 patients.
A clinical trial has shown that an inexpensive steroid called dexamethasone could prevent death in one out of eight ventilated COVID-19 patients and one out of 25 patients receiving oxygen only.
The European Commission (EC) granted marketing authorisation for Darzalex in combination with bortezomib, thalidomide and dexamethasone (VTd) for multiple myeloma patients.
The drug daratumumab has been approved for treatment of multiple myeloma, demonstrating increased efficacy when used in combination with other drugs.
Accelerated approval has been granted to Xpovio to treat refractory multiple myeloma by the FDA.
A treatment for amyloidosis has been pulled from clinical trials after failing to reach endpoints.