Smallpox vaccine approved for monkeypox prevention

The European Medicines Agency (EMA) has recommended extending the use of Imvanex, a smallpox vaccine, for the prevention of monkeypox infection in adults. The news came as the World Health Organisation (WHO) declared the ongoing monkeypox outbreak as a public health emergency of global concern.

The vaccine has been approved for the prevention of smallpox in the EU since 2013 but, given the similarities between smallpox and monkeypox viruses, it is considered to be protective against both. Animal studies suggest non-human primates vaccinated with Imvanex is effective in preventing monkeypox. Bavarian Nordic A/S, which holds the license for the vaccine, will collect data from an observational study to be conducted during the ongoing outbreak in Europe.

Along with extending the license of this vaccine, the EMA’s human medicines committee (CHMP) gave the green light to 11 new products at its meeting in late July. Other approved products include:

• Amvuttra* (vutrisiran) for the treatment of adults with hereditary transthyretin-mediated amyloidosis, a rare life-threatening disease that damages multiple nerves across the body.
• 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. The product is not intended for direct use in patients and must be used only for the radiolabelling of carrier medicines that have been specifically developed and authorised for radiolabelling with lutetium chloride.
• Lupkynis(voclosporin) for the treatment of lupus nephritis, an inflammation of the kidney caused by lupus.
• Mounjaro(tirzepatide) for the treatment of adults with type 2 diabetes mellitus.
• Nulibry (fosdenopterin) for the treatment of molybdenum cofactor deficiency type A – 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.
• Tecvayli (teclistamab) received conditional approval for the treatment of adults with relapsed and refractory multiple myeloma, who have received at least three prior therapies.
• Tezspire(Tezepelumab), intended as an add-on treatment in adult and adolescent patients with severe asthma.
• Vabysmo(faricimab) for the treatment of adults with neovascular age-related macular degeneration and visual impairment due to diabetic macular oedema.
• Thalidomide Lipomed(thalidomide) a hybrid medicine for the treatment of multiple myeloma. Hybrid medicines rely in part on the results of pre-clinical tests and clinical trials of an already authorised reference product and in part on new data.

The committee also recommended six extensions of indication for medicines that are already authorised in the EU: Genvoya, Imcivree, Retsevmo, Tecartus and Ultomiris.