FDA approves Dupixent, Darzalex, Soliris

The US Food and Drug Administration (FDA) has approved three new drugs, Soliris (eculizumab), Dupixent (dupilumab) and Darzalex (daratumumab).

Alexion’s Soliris (eculizumab) has been approved by the governing body for intravenous use for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive.

The company said that “The combination of lenalidomide and dexamethasone is broadly used by newly diagnosed patients with multiple myeloma ineligible for ASCT in the United States,” and that they are “extremely pleased that physicians can now offer their patients the option to add Darzalex to this regimen in the US.”

In patients with NMOSD, the body's immune system mistakenly attacks healthy cells and proteins in the body, most often in the optic nerves and spinal cord. Individuals with NMOSD typically have attacks of optic neuritis, which causes eye pain and vision loss. Individuals also can have attacks resulting in transverse myelitis, which often causes numbness, weakness, or paralysis of the arms and legs, along with loss of bladder and bowel control.

Genmab also announced that the organisation approved Darzalex (daratumumab) in combination with lenalidomide and dexamethasone for the treatment of adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant (ASCT).

This approval was based on data from the Phase III MAIA (MMY3008) study.

Finally, the governing body announced the approval of Sanofi’s Dupixent (dupilumab), as the first and only biologic treatment for adults with chronic rhinosinusitis with nasal polyposis (CRSwNP), whose disease is not adequately controlled. It is also “the only approved therapy shown to shrink nasal polyp size and also improve the signs and symptoms of the associated chronic rhinosinusitis,” according to George Yancopoulos, chief scientific officer at Regeneron.

CRSwNP is a chronic disease of the upper airway that obstructs the sinuses and nasal passages that may be driven by type II inflammation. Type II inflammation is an overactive response of the immune system that underlies conditions like atopic dermatitis, asthma and CRSwNP.

The FDA also evaluated the CRSwNP Dupixent application under Priority Review, which is reserved for medicines that represent potentially significant improvements in efficacy or safety in treating serious conditions.

http://www.pharmatimes.com/news/fda_approves_dupixent,_darzalex,_soliris_1292795