|Approval Dates and Comments
Betamethasone dipropionate 0.05% spray
In February 2016, the US FDA approved this topical corticosteroid spray formulation containing betamethasone dipropionate 0.05% for the treatment of mild to moderate plaque psoriasis in patients 18 years of age or older.
Dapsone 7.5% gel
In February 2016, the FDA granted marketing approval to dapsone 7.5% gel for the topical treatment of acne in patients 12 years of age and older. This once daily topical agent treats both inflammatory and non-inflammatory acne with a new concentration of dapsone.
Cobimetinib + vemurafenib
Cotellic™ + Zelboraf®
Hoffmann-La Roche Limited (Roche Canada)
In February 2016, Health Canada approved cobimetinib (MEKinhibitor) for use in combination with vemurafenib (BRAFinhibitor) as an oral treatment of patients with unresectable or metastatic melanoma with a BRAF V600 mutation. Combined inhibition of BRAF and MEK is thought to improve outcomes in melanoma by preventing or delaying the onset of resistance seen with BRAF inhibitor use alone.
Botulinum toxin type A for injection (incobotulinumtoxinA)
The European regulatory authorities approved this formulation of botulinum toxin type A in March 2016 for the treatment of upper facial lines, including horizontal frown lines, lateral periorbital lines and glabellar frown lines. Bocouture® is the only neurotoxin approved in Europe for the simultaneous treatment of upper facial lines. It has been available in the UK since 2008 under the tradename Xeomin®, which is licensed for blepharospasm and cervical dystonia. Cosmetic use in the UK was granted in July 2010 and is marketed for this indication under the brand name Bocouture®.
Calcipotriol + betamethasone dipropionate foam
Scientific approval in the EU of this fixed combination of calcipotriol/betamethasone dipropionate 50 µg/g / 0.5 mg/g was granted in March 2016 for the treatment of psoriasis vulgaris in patients 18 years of age or older.
Ixekizumab SC injection
Eli Lilly and Company
In January 2016, the FDA expanded its approval of secukinumab to include two new indications – the treatment of adult patients with active psoriatic arthritis and active ankylosing spondylitis. Secukinumab is a monoclonal antibody that inhibits IL-17A – elevated levels of this cytokine are associated with inflammatory diseases.
Infliximab-dyyb for IV infusion
In April 2016, the FDA approved Inflectra™ for multiple indications. Inflectra™ is biosimilar to Janssen Biotech’s Remicade® (infliximab), which was originally licensed in 1998. Approved uses include chronic severe plaque psoriasis, psoriatic arthritis, rheumatoid arthritis, ankylosing spondylitis, Crohn’s disease, and ulcerative colitis.
In April 2016, the Natural and Non-Prescription Health Products Directorate of Health Canada approved SD Cream and AD Cream. Additionally, European approval of Helioclin® Pruritus SD Cream (Pruridexin™) was granted in March 2016 as a Class III medical device. In Canada, the SD Cream is a barrier-repair cream for the management and relief of the signs and symptoms of seborrheic dermatitis (e.g., erythema, scaling and pruritis). AD Cream is for the management and relief of the signs and symptoms of atopic and contact dermatitis (e.g., erythema, scaling and pruritus).