NETHERLANDS – The European Medicines Agency (EMA) announced that its Committee for Medicinal Products for Human Use (CHMP) has recommended approval for 11 medicines at its July 2022 meeting.
The medicines treat a variety of conditions including cancer and type 2 diabetes.
The CHMP recommended granting a marketing authorization for Amvuttra (vutrisiran) for the treatment of adults with hereditary transthyretin-mediated amyloidosis, a rare life-threatening disease that damages multiple nerves across the body.
The committee adopted a positive opinion for Celdoxome pegylated liposomal (doxorubicin hydrochloride) for the treatment of metastatic breast cancer, advanced ovarian cancer, progressive multiple myeloma and Kaposi’s sarcoma, a type of cancer that affects people with AIDS.
Illuzyce (lutetium (177lu) chloride), a radiopharmaceutical precursor, received a positive opinion from the CHMP.
Illuzyce is not intended for direct use in patients and must be used only for the radiolabeling of carrier medicines that have been specifically developed and authorized for radiolabeling with lutetium chloride.
The CHMP recommended granting a marketing authorization for Lupkynis (voclosporin) for the treatment of lupus nephritis, an inflammation of the kidney caused by lupus.
Lupus is an auto-immune disease in which the body’s immune system attacks healthy tissues.
The committee adopted a positive opinion for Mounjaro (tirzepatide) for the treatment of adults with type 2 diabetes mellitus.
The CHMP gave a positive opinion under exceptional circumstances for Nulibry (fosdenopterin) for the treatment of molybdenum cofactor deficiency type A.
This is an ultra-rare condition that appears shortly after birth and leads to brain injury and death.
Opdualag (relatlimab /nivolumab), intended for the treatment of melanoma, a type of skin cancer, that has spread to other parts of the body and cannot be removed by surgery, received a positive opinion from the CHMP.
The medicines treat a variety of conditions including cancer and type 2 diabetes.
The committee recommended granting a conditional marketing authorization for Tecvayli (teclistamab) for the treatment of adults with relapsed and refractory multiple myeloma, who have received at least three prior therapies.
Multiple myeloma is a rare cancer of the bone marrow that affects plasma cells, a type of white blood cell that produces antibodies.
The CHMP gave a positive opinion for Tezspire (Tezepelumab), intended as an add-on treatment in adult and adolescent patients with severe asthma, a chronic condition that affects around 6% of the EU population.
Vabysmo (faricimab), intended for the treatment of adults with neovascular age-related macular degeneration and visual impairment due to diabetic macular edema, received a positive opinion from the committee.
Hybrid medicine Thalidomide Lipomed (thalidomide) received a positive opinion for the treatment of multiple myeloma.
Recommendations on extensions of 6 therapies
The committee recommended six extensions of indication for medicines that are already authorized in the EU: Genvoya, Imcivree, Retsevmo, Tecartus and Ultomiris.
The CHMP has also recommended an extension of the use of the smallpox vaccine Imvanex (live modified vaccinia virus Ankara) to include protecting adults from monkeypox and disease caused by vaccinia virus.
The committee has recommended that Rubraca (rucaparib camsylate) should no longer be used as third-line treatment for cancers of the ovary, fallopian tubes or peritoneum with a BRCA mutation in patients whose cancer has relapsed.
Covid-19 update
The CHMP recommended extending the use of COVID-19 vaccine Spikevax (elasomeran / COVID-19 mRNA vaccine (nucleoside-modified)) as a booster in adolescents from 12 to 17 years of age.
The committee also endorsed updating the product information to state that stability has been demonstrated for 12 months when Spikevax is stored under certain conditions.
The CHMP also recommended approving a new manufacturing site for the finished product in Madrid, Spain.
The committee recommended granting a full marketing authorization to Veklury (remdesivir), an antiviral medicine used to treat COVID-19, following the submission of data by the marketing authorization holder.
Veklury is used in adults and adolescents with pneumonia requiring supplemental oxygen. The medicine can also be used in adults who do not require supplemental oxygen and who are at increased risk of developing severe COVID-19.
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