|Name/Company||Approval Dates and Comments|
In September 2014, the US FDA granted an additional indication to this oral selective inhibitor of phosphodiesterase 4 (PDE4) for patients who have moderate-to-severe plaque psoriasis. Apremilast is an oral small molecule inhibitor of PDE4 specific for cyclic adenosine monophosphate (cAMP). PDE4 inhibition increases intracellular cAMP levels, resulting in suppression of immune responses. Apremilast was FDAapproved for the treatment of adults with active psoriatic arthritis in March 2014.
The FDA approved the supplemental Biologics License Application (sBLA) for this novel, first-in-class biologic in October 2014 for the treatment of up to two Dupuytren’s contracture cords in the same hand during a single treatment visit. Xiaflex® obtained FDA approval in 2010 as the first and only nonsurgical treatment for adult Dupuytren’s contracture patients with a palpable cord in the palm. The injected enzymes dissolve and weaken the contracted collagen cord.
Afamelanotide 16 mg
The European Medicines Agency (EMA) approved afamelanotide 16 mg implants in October 2014 to treat the genetic disorder erythropoietic protoporphyria (EPP), a painful photodermatosis. This photoprotective agent belongs to a family of drugs known as melanocortins and is the first ever treatment developed for EPP. Afamelanotide provides prophylactic treatment through its antioxidant effects and activation of melanin in skin, thereby providing patients with a biological barrier between their skin and the various wavelengths of light that trigger phototoxic reactions.
The FDA approved this fixed combination of a lincosamide antibacterial and an antimicrobial in November 2014 for the topical treatment of acne vulgaris in patients ≥12 years of age. Onexton™ is the first and only FDA-approved fixed-dose clindamycin phosphate 1.2% and benzoyl peroxide 3.75% medication for the once-daily treatment of comedonal (noninflammatory) and inflammatory acne. This preparation does not contain surfactants, alcohol or preservatives.
The FDA granted Breakthrough Therapy designation to dupilumab in November 2014 for the treatment of adults with moderate-to-severe atopic dermatitis (AD) who are not adequately controlled with topical prescription therapy and/or for whom these treatments are not appropriate. Dupilumab is an investigational therapy blocking IL-4 and IL-13, two cytokines required for the Th2 immune response. The designation is based on positive results from Phase 1 and 2 clinical trials. Treatment is administered by subcutaneous injection. The Phase 3 trial of this drug was initiated in October 2014.
Health Canada approved this orally available small molecule inhibitor of PDE4 in November 2014 for the treatment of patients with moderate-to-severe plaque psoriasis who are candidates for phototherapy or systemic therapy. As an inhibitor of PDE4, apremilast is the first in a new class of oral treatments for psoriasis. Inhibition of PDE4 suppresses both TNF-α production and immune response, which play important roles in the chronic inflammation associated with the development of skin symptoms in psoriasis. Canada is the second country to approve Otezla® for plaque psoriasis.