|Name/Company||Approval Dates and Comments|
Health Canada approved omalizumab (a recombinant humanized monoclonal antibody that blocks the highaffinity Fc receptor of immunoglobulin E) in August 2014 for the treatment of chronic idiopathic urticaria. This new use (already approved for asthma) is for patients ≥12 years of age who remain symptomatic despite H1-antihistamine therapy. Treatment is not indicated for other forms of urticaria (hives). The approved doses are 150 mg and 300 mg by subcutaneous injection every 4 weeks.
The US FDA granted accelerated approval to pembrolizumab in September 2014 for the treatment of patients with unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor. The drug acts by targeting the programmed cell death 1(PD-1) receptor. Pembrolizumab is a monoclonal antibody that binds to the PD-1 receptor and blocks its interaction with programmed cell death 1 ligand 1 (PD-L1) and PD-L2, thereby releasing PD-1 pathway-mediated inhibition of the immune response, including anti-tumor immune response. The recommended dose of pembrolizumab is 2 mg/kg administered as an intravenous infusion over 30 minutes every 3 weeks.This is the first PD-1 inhibitor to be marketed in the US. Several other companies, including Bristol- Myers Squibb and Roche Holding AG, also have compounds that target PD-1. Nivolumab (Opdivo®, Bristol-Myers Squibb) has already gained regulatory approval in Japan and is under review by the FDA.
The FDA approved this novel semisynthetic glycopeptide antibiotic in September 2014 to treat adults with acute bacterial skin and skin structure infections (ABSSSI) caused by certain susceptible bacteria, including Staphylococcus aureus (including methicillin-susceptible and methicillin-resistant strains), various Streptococcus species and Enterococcus faecalis. A 1200 mg single dose is administered by intravenous infusion over 3 hours. Oritavancin is the third new antibacterial drug approved by the FDA this year to treat ABSSSI. The agency approved dalbavancin (Dalvance™) in May 2014 and tedizolid phosphate (Sivextro™) in June 2014.
Calcipotriene 0.005% + betamethasone dipropionate 0.064% topical suspension
In September 2014, the FDA approved a new indication for this topical combination treatment for plaque psoriasis of the scalp in patients 12 to 17 years – the first indication for adolescent patients aged ≥12 years with scalp plaque psoriasis on the market. This once-daily combination product is indicated for treatment of both scalp and body plaque psoriasis in adults aged ≥18 for up to 8 weeks, and now for the treatment of plaque psoriasis of the scalp in pediatric patients aged 12 to 17 years for the same duration.
In September 2014, Epirus Biopharmaceuticals, Inc., a Boston-based biopharmaceutical company focused on the global development and commercialization of biosimilar monoclonal antibodies, announced that it has received final marketing and manufacturing approvals for its Remicade® (infliximab) biosimilar, BOW015, from the Drug Controller General of India (DCGI). BOW015 is the first infliximab biosimilar approved in India.