|Name/Company||Approval Dates and Comments|
Nivolumab IV infusion
The European Commission (EC) approved this human programmed death receptor-1 (PD-1) blocking monoclonal antibody in June 2015 for the treatment of advanced (unresectable or metastatic) melanoma in adults, regardless of BRAF status.
The EC approved this anti-PD-1 therapy in July 2015 for the treatment of advanced (unresectable or metastatic) melanoma in adults. Pembrolizumab received EC regulatory approval based on phase 3 data that showed it is the first and only antiPD-1 therapy to provide a statistically superior survival benefit as a monotherapy vs. ipilimumab, the current standard of care for advanced melanoma.
Sonidegib phosphate capsules
The US FDA approved sonidegib in July 2015 to treat patients with locally advanced basal cell carcinoma that has recurred following surgery or radiation therapy, or who are not candidates for surgery or radiation therapy. This once-daily oral treatment works by inhibiting a molecular pathway, called the Hedgehog pathway, which is active in basal cell cancers. By suppressing this pathway, sonidegib may inhibit the growth of cancerous lesions.
Azelaic acid 15% foam
The FDA approved azelaic acid 15% foam in July 2015 for the topical treatment of the inflammatory papules and pustules of mild to moderate rosacea.
Adapalene 0.3% + benzoyl peroxide 2.5% gel
The FDA approved this new formulation of adapalene 0.3% and benzoyl peroxide (BP) 2.5% gel in July 2015 for the once-daily, topical treatment of acne vulgaris. Epiduo® Forte Gel is the first combination of these strengths of the retinoid, adapalene, and BP, developed to treat moderate to severe acne.
Deoxycholic acid injection
Health Canada approved this first-in-class adipolytic agent in July 2015 for improvement in the appearance of moderate to severe convexity or fullness associated with submental fat (SMF) in adults. Treatment of fat outside of the submental area is not approved and is not recommended. Deoxycholic acid (ATX-101) is an injectable treatment for the reduction of SMF, which commonly presents as a double chin. The drug destroys fat cells when properly injected into SMF.
Erratum: Due to an editing error, the incorrect US FDA approval date of April 2014 for deoxycholic acid injection (Kybella™, Kythera Biopharmaceuticals) was inadvertently published in Skin Therapy Letter 2015 Jul-Aug;20(4):12. The correct approval date is April 2015. The publisher apologizes for any inconvenience.
Hyaluronic acid gel injectable dermal filler
Restylane® Lyft with Lidocaine
The FDA granted approval in July 2015 to market this injectable gel to increase volume and smooth wrinkles in the face of patients aged >21 years. Restylane® Lyft was formerly marketed as Perlane-L®. Restylane® Lyft with Lidocaine is indicated for implantation into the deep dermis to superficial subcutis for the correction of moderate to severe facial folds and wrinkles, such as nasolabial folds, and for subcutaneous to supraperiosteal implantation for cheek augmentation and correction of age-related midface contour deficiencies.
Dermal filler with calcium hydroxylapatite (CaHA) + integral 0.3% lidocaine
In July 2015, Health Canada approved Radiesse® (+) injectable implant dermal filler that contains a small quantity of local anesthetic (lidocaine). Radiesse® (+) is indicated for subdermal implantation for the correction of moderate to severe facial wrinkles and folds, such as nasolabial folds, and for rejuvenation of the hands.