The EMA’s committee has granted positive opinions for ten new treatments, including medicines for oncology indications and rare diseases.

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The Committee for Medicinal Products for Human Use (CHMP) has recommended ten medicines for approval in its latest meeting.

The committee recommended authorisation of three cancer medicines. The first, a conditional approval of Aucatzyl (obecabtagene autoleucel), to treat relapsed or refractory B-cell precursor acute lymphoblastic leukaemia.

Blenrep (belantamab mafodotin), a treatment for relapsed or refractory multiple myeloma was also granted a positive opinion.

Additionally, the committee recommended Itovebi (inavolisib) for adults with PIK3CA-mutated, oestrogen receptor (ER)-positive, HER2-negative locally advanced and metastatic breast cancer.

The committee recommended conditional approval of Ezmekly (mirdametinib), for paediatric and adult patients with the inherited condition neurofibromatosis type 1 with associated plexiform neurofibromas (NF1-PN).

The CHMP also adopted a positive opinion for Maapliv (amino acids), to treat the rare genetic disorder maple syrup urine disease (MSUD) under exceptional circumstances.

Riulvy (tegomil fumarate) was recommended for relapsing remitting multiple sclerosis. The committee granted this positive opinion for adults and children from 13 years old.

CHMP's approval of biosimilar medicines

While the CHMP recommended a variety of denosumab biosimilars for bone-related disorders in its April meeting, this time, three biosimilar medicines were recommended for approval for this indication:

  • Bomyntra (denosumab) was granted a positive opinion to prevent skeletal related events in adults with advanced malignancies involving bone. Additionally, the treatment was recommended for adults and skeletally mature adolescents with giant cell tumour of bone.
  • The CHMP gave a positive opinion for Conexxence (denosumab) and Rolcya (denosumab) for osteoporosis. The latter treatment was also recommended for bone loss.

Generic medicine Emtricitabine/Tenofovir alafenamide Viatris (emtricitabine / tenofovir alafenamide), received a positive opinion to treat adults and adolescents with human immunodeficiency virus type 1 (HIV-1).

CHMP’s negative opinions

Two medicines were given negative opinions at the May meeting. Firstly, Atropine sulfate FGK (atropine) was not recommended for paediatric-use in children aged three years and older who have myopia.

Secondly, Kinselby (resminostat) was not given a positive opinion to treat two cancers: advanced stage mycosis fungoides and Sezary syndrome.

Indication extensions

The committee recommended the extension of indications for Imfinzi, Rezolsta, Saxenda and Tevimbra.

CHMP's re-examinations of recommendation approvals

The European Commission requested a re-examination of the CHMP’s negative opinion adopted in December 2017 for Aplidin (plitidepsin), a medicine intended to treat multiple myeloma. This is following the European Commission revoking the refusal of a marketing authorisation for the treatment on 28 June last year.

The marketing authorisation holder for Winlevi (clascoterone) as a treatment for acne vulgaris, requested a re-examination of the negative opinion adopted during the committee’s meeting last month. The CHMP will issue its final recommendations of the medicine in due course.

Application withdrawals

Despite the CHMP granting two positive opinions for biosimilars to treat osteoporosis, an initial marketing authorisation application for Teriparatide Ascend (teriparatide) intended for this indication, was withdrawn.

Secondly, the committee also withdrew an application to extend the therapeutic indication of Lutathera (lutetium (177Lu) oxodotreotide) for adults with newly diagnosed gastroenteropancreatic neuroendocrine tumours.

Start of referral

The CHMP has started a review of available information on the benefits and risks of ipidacrine-containing medications, largely indicated to treat disorders affecting the nervous system. The Irish medicines regulatory agency, requested this action under Article 31 of Directive 2001/83/EC.

Conclusion of referral

Lastly, the committee finalised its review of the antibiotic azithromycin. Several changes, including revisions and removals of certain indications, were recommended.

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