Five new medicines are a giant leap closer to entering the European market after having been recommended for approval by the European Medicines Agency's Committee for Medicinal Products for Human Use.
First up, the CHMP has adopted a positive opinions for two new drugs intended to treat rare blood cancers: Janssen-Cilag's Imbruvica (ibrutinib) and Gilead's Zydelig (idelalisib).
Their approval is being recommended to treat adult patients with chronic lymphocytic leukaemia (CLL) who have received at least one prior treatment, as well as a first-line option for those with a specific genetic mutation that makes them unsuitable for chemo-immunotherapy.
Imbruvica has also been endorsed as a treatment for adults with relapsed or refractory mantle cell lymphoma (MCL), while Zydelig also won backing for treating patient with refractory follicular lymphoma.
The drugs have the potential to bring new treatment options for patients suffering from these rare cancers, especially in cases where previous treatments have stopped working, as they act in different ways to previously authorised medicines, health officials noted.
Elsewhere, agency advisors supported approval of Novo Nordisk's Xultophy (insulin degludec / liraglutide), a new treatment for type II diabetes.
The benefits with Xultophy are its clinically relevant effect on glycaemic control in patients with type 2 diabetes when used in combination with other oral glucose-lowering medicinal products, while the drug has a neutral effect on body weight, the CHMP noted.
Accord Healthcare's biosimilar Accofil was given the green light for approval as a treatment for neutropenia, while Fresenius Kabi Oncology's generic drug busulfan got the nod as a conditioning treatment prior to conventional haematopoietic progenitor cell transplantation.
The CHMP also recommended expanding indications for a stream of medicines already on the market.
Among these, Allergan's eye implant Ozurdex got the thumbs up for the treatment of adult patients with vision loss due to diabetic macular oedema (DME), specifically in those who are pseudophakic (have an artificial lens following cataract operation) or who are considered insufficiently responsive to or unsuitable for non-corticosteroid treatment.
DME is a condition that affects around 7% of patients with diabetes, and is the leading cause of sight loss in patients with diabetes.
Ozurdex has been approved for DME in the US among other indications, and is also on the market in Europe for macular odema in patients with retinal vein occlusion and uveitis.