|Name/Company||Approval Dates and Comments|
Health Canada approved bilastine 20 mg oral tablet in April 2016 for treating the symptoms of seasonal allergic rhinitis and chronic spontaneous urticaria (such as itchiness and hives). This is the first new antihistamine introduced in Canada in over 15 years.
Ixekizumab SC injection
Eli Lilly and Company
In April 2016, the European Commission (EC) granted marketing authorization for ixekizumab for the treatment of moderate-tosevere plaque psoriasis in adults who are candidates for systemic therapy. Ixekizumab is an antibody specifically designed to target the cytokine interleukin IL-17A, a protein that plays a role in driving underlying inflammation in psoriasis. The approved dosing regimen for ixekizumab is a 160 mg SC injection, followed by an 80 mg injection every 2 weeks for 12 weeks and then a maintenance monthly dose of 80 mg.
Wound care gel
Oculus Innovative Sciences
US FDA 510(k) clearance was granted to Microcyn®-based Lasercyn™ gel in April 2016. Under the supervision of a healthcare professional, Lasercyn™ gel is intended for the management of post-nonablative laser therapy procedures, postmicrodermabrasion therapy and following superficial chemical peels. Lasercyn™ may also be used to relieve itch and pain from minor skin irritations, lacerations, abrasions and minor burns. CE Marks in Europe were gained in March 2016.
The FDA approved a supplemental New Drug Application in May 2016 for ceftaroline fosamil, an IV antibiotic, which grants new indications for pediatric patients 2 months of age to less than 18 years of age with acute bacterial skin and skin structure infections (ABSSSI), including infections caused by methicillinresistant Staphylococcus aureus (MRSA), and communityacquired bacterial pneumonia (CABP) caused by Streptococcus pneumoniae and other designated susceptible bacteria.
Nivolumab + ipilimumab
Opdivo® + Yervoy®
Bristol-Myers Squibb Company
In May 2016, the EC approved nivolumab (Opdivo®, anti-PD-1 monoclonal antibody) in combination with ipilimumab (Yervoy®, anti-CTLA-4 monoclonal antibody) for the treatment of advance (unresectable or metastatic) melanoma in adults. This approval allows for the marketing of the combination IV regimen in all 28 EU Member States
PDT for actinic keratosis
Ameluz® gel + BF-RhodoLED®
In May 2016, the FDA approved the topical prescription drug Ameluz® (aminolevulinic acid, a porphyrin precursor) for use in combination with the BF-RhodoLED® lamp for photodynamic therapy (PDT) treatment of mild to moderate actinic keratoses on the face and scalp. This approval covers lesion-directed as well as field-directed treatment.
In May 2016, the FDA issued an update to its Drug Safety Communication from 2013 limiting the usage of ketoconazole (Nizoral®) oral tablets due to potentially fatal liver injury and risk of drug interactions and adrenal gland problems. Healthcare professionals are warned to avoid prescribing the antifungal medicine ketoconazole oral tablets to treat skin and nail fungal infections. Label changes for oral ketoconazole tablets in 2013 reflected these serious risks and removed the indications for treatment of skin and nail fungal infections. However, an FDA safety review found that oral ketoconazole continues to be prescribed for these types of conditions. Since the 2013 labeling change, one death has been reported to the FDA due to liver failure associated with oral ketoconazole prescribed to treat a fungal infection of the nails. For more information: http://www.fda.gov/Drugs/DrugSafety/ucm500597.htm