Six new medicines have cleared a key hurdle on the path to European approval after winning favour with regulatory advisors.
The latest round of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) includes innovative cell-based therapy MolMed's Zalmoxis, designed to support stem cell transplantation in patients with high-risk blood cancer.
The Committee is supporting a conditional marketing authorisation for the drug as an adjunctive, or add-on, treatment for adult patients receiving a haploidentical haematopoietic stem cell transplant (HSCT) for types of blood cancer to aid immune reconstitution and reduce the risk of graft-versus-host disease.
Zalmoxis consists of T cells from the stem cell donor, which have been separated from the rest of the cells in the transplant and have been genetically modified to include a 'suicide gene' called HSV-TK.
T cells are given to transplant patients to help the body fight off infection, boost the success of the transplant and support long-lasting anti-cancer effects; however they can also cause graft-versus-host disease (GVHD). The suicide gene in Zalmoxis makes the T cells susceptible to a medicine called ganciclovir, which is given in the event of GVHD.
Clinical trial data show that, of 30 patients with blood cancers who had had haploidentical HSCT, 23 had their immune systems restored. GVHD occurred in ten patients, nine of which were given ganciclovir; none died or suffered long-term serious effects.
Elsewhere, Teva Pharmaceutical's biologic Cinqaero (reslizumab) was endorsed as an add-on treatment for adult patients with severe eosinophilic asthma.
The drug, a humanised interleukin-5 antagonist monoclonal antibody produced by recombinant DNA technology, was approved by US regulators in March.
"In clinical trials, reslizumab was effective in reducing asthma exacerbations, improving lung function and improving asthma-related quality of life measures," said Rob Koremans, president and chief executive of Teva Global Specialty Medicines. "It is our hope that we can expand the availability of reslizumab globally and soon bring this important treatment option to a specific group of severe eosinophilic asthma patients in Europe who struggle to control their symptoms despite today's standard of care."
Mylan's generic Atazanavir Mylan (atazanavir) was recommended for the treatment of human immunodeficiency virus-1 (HIV-1) infections.
Three hybrid applications - which partly rely on results from preclinical tests and clinical trials for a reference product and in part on new data - also won CHMP backing: Teva B.V's Aerivio Spiromax and Airexar Spiromax, both containing salmeterol xinafoate and fluticasone propionate, for asthma and chronic obstructive pulmonary disorder (COPD); and Nordic Group's Nordimet (methotrexate) for active rheumatoid arthritis, juvenile idiopathic arthritis and severe psoriatic arthritis.