Eight new medicines recommended for approval

EMA’s human medicines committee (CHMP) recommended eight medicines for approval at its March 2020 meeting. In line with EMA’s measures to limit the spread of COVID-19, the meeting was held virtually.

The Committee recommended granting a conditional marketing authorisation for Zolgensma* (onasemnogene abeparvovec), an advanced therapy medicinal product (ATMP) for the treatment of babies and young children with spinal muscular atrophy, a rare and often fatal genetic disease that causes muscle weakness and progressive loss of movement. For more information, see the press release in the grid below.

The CHMP adopted a positive opinion for Atectura Breezhaler (indacaterol / mometasone furoate) and Bemrist Breezhaler (indacaterol / mometasone furoate) for the treatment of asthma.

The Committee recommended granting a marketing authorisation for Fluad Tetra (influenza vaccine (surface antigen, inactivated, adjuvanted)) for prophylaxis against influenza.

Pretomanid FGK* (pretomanid) received a positive opinion from the CHMP for the treatment of tuberculosis in combination with bedaquiline and linezolid.

The CHMP recommended granting a marketing authorisation for Sarclisa* (isatuximab) for the treatment of multiple myeloma, a cancer of the bone marrow.

Zeposia (ozanimod) received a positive opinion for the treatment of adult patients with relapsing remitting multiple sclerosis with active disease.

The biosimilar medicine Nepexto (etanercept) received a positive opinion for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, axial spondyloarthritis (ankylosing spondylitis, non-radiographic axial spondyloarthritis), plaque psoriasis and paediatric plaque psoriasis.

Six recommendations on extensions of therapeutic indication

The Committee recommended extensions of indication for AdcetrisCosentyxIntelenceJorvezaKineret, and Ruconest.

Outcome of review on direct oral anticoagulants

No change to the conditions of use of the direct oral anticoagulants Eliquis (apixaban), Pradaxa (dabigatran etexilate) and Xarelto (rivaroxaban) is needed following a review of the results of a European study of real-world data for these medicines. The study assessed the risk of serious bleeding with these three medicines when used to prevent blood clotting in patients with non-valvular atrial fibrillation (irregular rapid contractions of the heart) and compared this with other oral anticoagulants called vitamin K antagonists.

For more information, see the public health recommendation in the grid below.

Outcome of review on fosfomycin medicines

The Committee recommended that fosfomycin medicines given by infusion (drip) into a vein should only be used to treat serious infections when other antibiotic treatments are not suitable. Fosfomycin medicines given by mouth can continue to be used to treat uncomplicated bladder infections in women and adolescent girls. They can also be used to prevent infection in men undergoing a procedure whereby a tissue sample is taken from their prostate (biopsy).

Fosfomycin medicines given by mouth to children (under 12 years of age) and intramuscular formulations (fosfomycin medicines for injection into a muscle) should no longer be used. These recommendations follow a review of the safety and effectiveness of these antibiotics. For more information, see the public health recommendation in the grid below.

Outcome of review on methocarbamol / paracetamol-containing medicines

The CHMP concluded that the benefits of medicines containing methocarbamol and paracetamol continue to outweigh their risks in the short-term treatment of painful muscle spasms. A review was started as recent publications had raised questions about the effectiveness of the combination of these substances at treating conditions such as low back pain in the doses at which they are present in these medicines.

For more information, see the public health recommendation in the grid below.

Update on nitrosamine impurities – step 1 risk evaluation deadline extended

In consideration of the challenges caused globally to health regulators and industry by the COVID-19 pandemic, the European medicines regulatory network has agreed to extend the deadline for the risk evaluation referred to in the “Information on nitrosamines for marketing authorisation”. Marketing authorisation holders who are currently reviewing their medicines for the possible presence of nitrosamines will now have until 1 October 2020 to submit the results of the step 1 risk evaluation.

For more information on the review, please see our website.

Outcome of review of study data for Tyverb

The product information for Tyverb (lapatinib), a breast cancer medicine, will continue to state that no data are available on the effectiveness of Tyverb used together with an aromatase inhibitor compared with trastuzumab used with an aromatase inhibitor in patients previously treated with trastuzumab. EMA updated the product information for this medicine in April 2019 following detection of errors in results of a study involving postmenopausal women who had ‘HR+/HER2+’.

For more information, see our website.

Withdrawals of applications

The application for an initial marketing authorisation for Doxorubicin Hydrochloride Tillomed (doxorubicin) was withdrawn. This hybrid medicine was intended for the treatment of breast and ovarian cancer, multiple myeloma and AIDS-related Kaposi’s sarcoma.

The applications for initial marketing authorisation for two medicines with the active substance rituximab were also withdrawn. These biosimilar medicines were intended for the treatment of certain blood cancers and inflammatory conditions.

Posted on the EMA website on 27 March 2020