CHMP recommends four new medicines, including first-in-class treatment for follicular lymphoma
Corrected 27 April 2022*The European Medicine Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) on Friday recommended four new medicines for authorization, including the EU’s first-in-class bispecific antibody for patients with relapsed or refractory follicular lymphoma (FL). The agency also announced that three applications were withdrawn, including Biogen’s application for its Alzheimer’s disease drug Aduhelm (aducanumab).
The new bispecific antibody, Roche’s Lunsumio (mosunetuzumab), will be available as 1 mg and 30 mg concentrate for solution for infusion, according to an announcement of the decision. The active substance, mosunetuzumab, is a bispecific monoclonal antibody which “simultaneously binds to CD20 on B cells and CD3 on T cells, thereby inducing the death of malignant B cells.”
The treatment benefits are the high proportion of patients responding to the medicine, while the side effects include cytokine release syndrome, neutropenia, pyrexia, hypophosphataemia and headache.
According to announcement from Roche, follicular lymphoma is the second most common form of lymphoma globally, and accounts for 20% of all non-Hodgkin lymphomas (NHF) diagnosed worldwide. More than 28,000 people in Europe are diagnosed with FL each year and most patients relapse within five years after initial treatment. Roche said if approved, “mosunetuzumab will be a first-in-class CD20xCD3 T-cell engaging bispecific antibody in NHL.”
Other medicines recommended for approval are Amryt’s Filsuvez (birch bark extract) for treating epidermolysis bullosa and Novartis’ Tabrecta (capmatinib) for treating advanced non-small cell lung cancer.
One generic medicine, Alfred E. Tiefenbacher’s Pirfenidone (pirfenidone) was recommended for treating idiopathic pulmonary fibrosis.
Seven extensions recommended
In other actions, CHMP recommended extending the indications for seven medicines: AstraZeneca’s Bydureon (exenatide), N.V. Organon’s Elonva (corifollitropin alfa), Merck’s Keytruda (pembrolizumab), Novo Nordisk’s NovoSeven (eptacog alfa), Eli Lilly’s Retsevmo (selpercatinib), Roche’s Tecentriq (atezolizumab) and Kite Pharma’s Yescarta (axicabtagene ciloleucel).
CHMP also recommended the approval of two treatments for diabetes mellitus outside the EU: Novo Nordisk’s Actrapid and Insulatard’s human insulin products. The two medicines were submitted under the EU-Medicines for all (EU-M4All) framework under Article 58 of Regulation (EC) No. 726/2004.
The CHMP also confirmed its original recommendation for Biogen’s Tecfidera (dimethyl fumarate) following a re-examination of its decision adopted on 27 January 2022. It also adopted a revised opinion for ObsEva Ireland’s Yselty (linzagolix choline) after receiving additional safety information. The medicine treats moderate to severe symptoms of uterine fibroids.
Three applications were withdrawn: Biogen’s Aduhelm (aducanumab) for treating Alzheimer’s disease, Orphazyme's Miplyffa (arimoclomal) for treating Niemann-Pick disease; and Ars Pharmaceuticals’ Neffy (epinephrine) for treating allergic reactions.
In related actions, CPMP started reviewing Clovis Oncology’s Rubraca (rucaparib) for treating cancer of the ovaries and fallopian tubes in patients with a BRCA mutation whose cancer has returned. Physicians were advised not to start patients on this medicine while the review is ongoing.
EMA
*This article has been corrected to clarify that Orphazyme withdrew Miplyffa. Regulatory Focus regrets the error.
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