June 3, 2013 | By Márcio Barra
EMa’s CHMP 27 – 30 May 2013 saw 7 new drugs attaining marketing authorization (MA). Here is the rundown of approvals:
Approved marketing authorizations for new drugs
Imvanex (Modified Vaccinia Ankara virus), Bavarian Nordic A/S – A vaccine recommended to be used for “active immunization against smallpox in adults”. It can be used either as primary vaccination, or as booster vaccination. In contrast with other smallpox vaccines, the attenuated Modified Vaccinia Ankara virus is non-replicating, which means that it does not proliferate in the body.
Imvanex has been developed since 2003 under contracts with the U.S. Government, for the “Project Bioshield”.
Lojuxta (lomitapide), Aegerion Pharmaceuticals – A selective inhibitor of microsomal transfer protein (MTP), a protein responsible for binding and shuttling lipids between cell membranes. MTP inhibition reduces lipoprotein secretion and circulating concentrations of lipoprotein-borne lipids like cholesterol and triglycerides. The MA states that the drug is to be used as an adjunct to a low fat diet and other lipid lowering products in adult patients with homozygous familial hypercholesterolaemia.
Lonquex (lipegfilgrastim), Teva Pharma B.V. – A immune system stimulator, which regulates the production and release of neutrophils from the bone marrow. It is used as an injectable intended for prophylaxis against chemotherapy-induced neutropenia, a disorder where the body produces an abnormally low number of neutrophils.
Pomalidomide Celgene (pomalidomide), Celgene Europe Ltd. – An orphan medicinal product, containing omalidomide, an immunomodulating agent with direct anti-myeloma tumouricidal activity and inhibits stromal cell support for multiple myeloma tumour cell growth. It is to be used in combination with dexamethasone for the treatment of relapsed and refractory multiple myelomas who have received at least two prior treatment regimens.
This drug has an expected teratogenic effect, so it shouldn’t be used by pregnant woman.
Somatropin Biopartners (somatropin), BioPartners GmbH – Somatropin is a recombinant human growth hormone, with biological effects equivalent to those of human growth hormone. The intended indications are the long-term treatment of growth failure in children and adolescents due to insufficient secretion of growth hormone, and as replacement therapy of endogenous growth hormone in adults with growth hormone deficiency.
Voncento (Human coagulation factor VIII, human Von Willebrand factor), CLS Behring GmbH – This medicine contains human coagulation factor VIII and human Von Willebrand factor, substances that help the blood to clot. It is approved for the treatment of Von Willebrand disease (VWD) and Haemophilia A (congenital factor VIII deficiency). Patients with haemophilia A lack factor VIII and patients with Von Willebrand disease lack Von Willebrand factor.
Atosiban Sun (atosiban), Sun Pharmaceutical Industries Europe B.V. – A generic of the drug Tractocile, which has been authorised in the EU since 20 January 2000, containing the active substance atosiban. It is approved for the delay of imminent pre-term birth in pregnant adult women.
For the remaining decisions, please check EMA’s website.