The European Union鈥檚 healthcare regulator the European Medicines Agency (EMA) has decided against a label expansion for GlaxoSmithKline ()鈥檚 drug Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol) to include asthma.
The EMA also made the same decision for two duplicate GSK products, Elebrato Ellipta and Temybric Ellipta.
Trelegy Ellipta was approved in Europe in November 2017 to relieve symptoms of moderate to severe chronic obstructive pulmonary disease (COPD). GSK was seeking to update the EMA鈥檚 marketing authorisation for Trelegy Ellipta, which is a single inhaler triple therapy. GSK鈥檚 label expansion called for the drug to be used as a maintenance treatment in adults with asthma who could not control their symptoms with standard-of-care treatment of corticosteroid and long-acting beta-2 agonist (LABA).
GSK鈥檚 application was based on the Phase III CAPTAIN study comparing Trelegy Ellipta with only fluticasone furoate and vilanterol in more than 2,000 patients who were able to control their asthma with a LABA and corticosteroid. The primary endpoint of the study was improvement in lung function measured by the change in FEV1 after 24 weeks of treatment.
The EMA decided that improvement in lung function was insufficient to suggest that the COPD drug was suitable for treating asthma. The regulator also : 鈥淭he main study did not clearly show that the medicine was effective at reducing asthma attacks or controlling symptoms.鈥�
The decision comes around six months after the US Food and Drug Administration (FDA) approved the expansion of Trelegy Ellipta鈥檚 label to include asthma based on results from the same Phase III CAPTAIN study. In response to the September , GSK president of R&D and chief scientific officer Dr Hal Barron said: 鈥淢illions of asthma patients in the US rely on multiple inhalers to help control their condition and manage their symptoms.
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By GlobalData“Today鈥檚 approval is an important advance for these patients as it allows them to benefit from triple therapy by using one inhaler, once-a-day.鈥�
Latest CHMP recommendations
The EMA鈥檚 opposing negative decision regarding GSK鈥檚 Trelegy Ellipta was made at a recent meeting of the regulator鈥檚 Committee for Medicinal Products for Human Use (CHMP).
At the same meeting, the CHMP decided to recommend six new medicines for approval. One example is GSK鈥檚 Jemperli (dostarlimab), which received a conditional marketing authorisation in certain types of recurrent or advanced endometrial cancer.
Jemperli is an anti-programmed death-1 monoclonal antibody indicated for endometrial cancer patients whose disease has progressed after platinum-based treatment. GSK is still awaiting FDA approval of Jemperli for this indication.
Another medicine recommended for approval by the CHMP was and Genentech鈥檚 Evrysdi (risdiplam) for spinal muscular atrophy patients aged over two months with a clinical diagnosis. Evrysdi is approved in seven countries so far, including the US, Russia, Chile and South Korea.
PTC Therapeutics CEO Stuart Peltz said: “Today’s CHMP opinion marks another important advancement in ensuring Evrysdi is available to SMA patients around the globe.
“Given its proven efficacy and strong safety profile, coupled with the convenience of an at-home administration, we expect Evrysdi to become the treatment of choice for SMA patients and their families.”
The CHMP also recommended label expansions for five medications: 鈥檚 Cabometyx (cabozantinib), GW Pharma鈥檚 Epidyolex (cannabidiol oral solution), 鈥檚 Opdivo (nivolumab), Menarini鈥檚 antibiotic Quofenix (delafloxacin) and 鈥檚 Sarclisa (isatuximab).
The CHMP also announced it has completed its review of the use of Regeneron and Roche鈥檚 monoclonal antibodies REGEN-COV (casirivimab and imdevimab) to treat Covid-19. The committee decided that the antibody combination therapies can be used to treat confirmed patients who do not require supplemental oxygen but are at a high risk of disease progression.
This antibody combination was granted emergency use authorisation by the FDA in November 2020. In the US, REGEN-COV is indicated for adults and over 12s weighing at least 40kg, with confirmed Covid-19 and at high risk of progressing to severe Covid-19 or being hospitalised.
Finally, linked with the CHMP meeting, the EMA has published to manufacturers seeking to modify their Covid-19 vaccines to address emerging Covid-19 variants. The EMA鈥檚 guidance paper calls for companies to demonstrate the efficacy of a variant vaccine against the variant strains by providing immunogenicity data. This can be garnered either after primary vaccination with the new, variant vaccine in a Covid-19 na茂ve unvaccinated population, or after a single dose of the variant vaccine given to individuals who have previously been vaccinated with the company鈥檚 original, parent vaccine.
This occurs in the context of the FDA publishing similar guidance for both vaccine and therapeutic manufacturers to combat new Covid-19 variants.
