|Name/Company||Approval Dates and Comments|
Brimonidine tartrate 0.33% topical gel
The US FDA approved this alpha-2 adrenergic receptor agonist in August 2013 for the topical treatment of the facial erythema (redness) of rosacea in adults ≥18 years of age. It is not indicated for the treatment of inflammatory lesions (papules and pustules). Brimonidine is thought to work by constricting dilated facial blood vessels to reduce the redness of rosacea. The drug has a rapid onset of action, with effects occurring as quickly as 30 minutes after application and lasting up to 12 hours.
The FDA granted marketing approval to the orphan drug Valchlor™ gel in August 2013 for the once-daily topical treatment of stage IA and IB mycosis fungoides-type cutaneous T-cell lymphoma (CTCL) in patients who have received prior skin-directed therapy. Mechlorethamine (nitrogen mustard) is a chemotherapeutic agent that was previously approved for the intravenous treatment of mycosis fungoides, the most common type of CTCL.
OnabotulinumtoxinA for injection
The FDA approved an additional indication to this neuromuscular paralytic agent in September 2013 for the temporary improvement of moderate to severe lateral canthal lines (crow’s feet). With this most recent approval, onabotulinumtoxinA is the only pharmaceutical indicated to treat both lateral canthal and glabellar lines.
In September 2013, the FDA approved an additional indication for this fully human anti-interleukin (IL)-12 and anti-IL-23 monoclonal antibody (mAb) to be used alone or in combination with methotrexate for the treatment of adult patients aged ≥18 years with active psoriatic arthritis.
The FDA approved certolizumab pegol in September 2013 for the treatment of adult patients with active psoriatic arthritis, which represents the third US approved indication for this humanized tumor necrosis factor-alpha inhibitor mAb.
In September 2013, the European Commission (EC) approved Inflectra™ (infliximab; innovator product Remicade®, Janssen), Europe’s first biosimilar mAb therapy for the treatment of inflammatory diseases including psoriasis, psoriatic arthritis, rheumatoid arthritis, ankylosing spondylitis, Crohn’s disease, and ulcerative colitis. Inflectra™ is the first mAb to be approved through the European Medicines Agency (EMA) biosimilars regulatory pathway.
Efinaconazole 10% topical solution
Health Canada approved efinaconazole 10% topical solution in October 2013 for the treatment of mild to moderateonychomycosis. Efinaconazole is the first topical triazole antifungal agent developed for distal lateral subungual onychomycosis (DLSO). This is the first regulatory approval world-wide for the drug.
Launched in Canada in September 2013 was the new fixed-dose Clindoxyl® ADV gel (GlaxoSmithKline Inc.) consisting of clindamycin phosphate 1% with a lower strength benzoyl peroxide (BP) component of 3% (vs. 5% in the parent product) for the topical treatment of moderate acne vulgaris. The lower BP concentration and preservative-free formulation improves tolerability with efficacy similar to the original product.
In August 2013, Biocon Limited announced the launch in India of its first-in-class novel biologic itolizumab (Alzumab™), the first anti-CD6 humanized monoclonal antibody to be introduced for treating patients with moderate to severe chronic plaque psoriasis. Marketing authorization for this indication was granted to itolizumab in January 2013 by the Drugs Controller General of India (DCGI).