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CHMP Opinions | EMA drug approvals

March 2021 CHMP Positive Opinion

Verastem’s Copiktra (duvelisib) received CHMP positive opinion for treating CLL and FL

CHMP gave a positive opinion for Verastem’s Copiktra (duvelisib) for treating relapsed or refractory chronic lymphocytic leukemia (CLL) and refractory follicular lymphoma (FL).

In the clinical trials, Copiktra had shown improvement in progression-free survival versus ofatumumab in patients who received two prior treatments. Respiratory tract infections, neutropenia, anemia, thrombocytopenia were the common adverse reported with the drug.

Copiktra is available in 15 mg and 25 mg capsules. The drug acts by inhibiting phosphatidylinositol 3-kinase p110δ (PI3K-δ) and PI3K-γ.

The drug has been previously approved by the US FDA and is marketed by Secura Bio.

Also read: United States healthcare system

CHMP gave a positive opinion for Janssen’s Ponvory to treat multiple sclerosis

CHMP gave a positive opinion for Janssen’s Ponvory (ponesimod) to treat adult patients with relapsed multiple sclerosis.

The positive opinion was based on the Phase 3 OPTIMUM study, a multicentre, randomized, double-blind, parallel-group study, which is intended to demonstrate the superiority of Ponvory over Aubagio (teriflunomide).

Ponvory demonstrated superiority versus Aubagio in reducing the annual relapsed rate (ARR) by 30.5%, the primary endpoint. It showed superiority in the secondary endpoint (unique active lesions).

Efmody (hydrocortisone) received a positive opinion to treat congenital adrenal hyperplasia (CAH)

Diurnal Europe BV received a positive opinion for Efmody (hydrocortisone) for treating congenital adrenal hyperplasia.

Also read: Denmark healthcare system

GSK’s Benlysta received a positive opinion for active lupus nephritis

GlaxoSmithKline announced that CHMP gave a position opinion for Benlysta (belimumab) to treat adult patients with active lupus nephritis.

The approval is based on Phase 3 BLISS-LN study, with Primary Efficacy Renal Response at two years (or 104 weeks) as the primary endpoint. Benlysta has demonstrated significant improvement compared to the standard of care plus placebo combination.

In December 2020, GSK received the FDA approval for Benlysta to treat patients with lupus nephritis.