The Scottish Medicines Consortium has recommended AbbVie's Humira (adalimumab) for use on the NHS in Scotland, the first and only treatment for hidradenitis suppurativa – a painful skin condition also called HS or acne inverse.
UK-based Martindale Pharma has had its Prenoxad Injection approved in Sweden, Denmark, Ireland, Finland and Estonia following the successful completion of a decentralised procedure (DCP). Prenoxad Injection is the world's first take-home naloxone product, designed for use by non-healthcare professionals to treat opioid overdoses in a community setting. Prenoxad Injection is already available in the UK. In addition, Martindale has announced the out-licensing of exclusive commercial rights to Prenoxad Injection for France to Ethypharm, a pain and addiction focused specialty pharmaceutical company. Financial terms were not disclosed.
Provepharm has received FDA approval for its ProvayBlue (methylene blue), making it the first methylene blue injection approved in the United States. In June 2013, the FDA granted Orphan Drug Designation for the drug. It has previously been approved by the FDA.
The European Commission has approved Bristol-Myers Squibb's Opdivo (nivolumab) and Yervoy (ipilimumab) regimen for the treatment of advanced melanoma, marking the fifth EU approval for the drug in three distinct tumour types. The EC has also approved Empliciti (elotuzumab) for the treatment of multiple myeloma as combination therapy with Revlimid (lenalidomide) and dexamethasone in patients who have received at least one prior therapy.
Opdivio has also been approved by the FDA for the treatment of Hodgkin lymphoma that has relapsed or progressed after autologous hematopoietic stem cell transplantation (auto-HSCT) and post-transplantation brentuximab vedotin.
Sobi and Biogen's Alprolix (rFIXFc) has been approved by the European Commission for the treatment of haemophilia B. Sobi and Biogen collaborate on the development and commercialisation of Alprolix. Sobi has final development and commercialisation rights in the Sobi territory (essentially Europe, North Africa, Russia and most Middle Eastern markets). Biogen leads development and manufacturing for Alprolix and has commercialisation rights in North America and all other regions in the world excluding the Sobi territory.
The FDA has approved an additional indication for Eisai's in-house developed novel anticancer agent Lenvima (lenvatinib mesylate) in combination with everolimus as a treatment for patients with advanced renal cell carcinoma following one prior anti-angiogenic therapy. Lenvima was designated as a Breakthrough Therapy by the FDA and also received a Priority Review.
Actelion's Uptravi (selexipag), a selective IP prostacyclin receptor agonist, has been granted marketing authorisation for the long-term treatment of pulmonary arterial hypertension (PAH) by the European Commission. Uptravi has been licensed for the long-term treatment of PAH in adult patients with WHO functional class (FC) II-III, either as a combination therapy in patients insufficiently controlled with an endothelin receptor antagonist (ERA) and/or a phosphodiesterase type 5 (PDE-5) inhibitor, or as monotherapy in patients who are not candidates for these therapies.