|Name/Company||Approval Dates and Comments|
Varicose vein procedure n-butyl-2-cyanoacrylate adhesive polymer + delivery system components
VenaSeal™ Closure System
The US FDA approved the first adhesive varicose vein treatment in February 2015. VenaSeal™ closure system is the only non-tumescent, non-thermal, non-sclerosant procedure to permanently treat varicose veins of the legs by sealing the affected superficial veins using an adhesive agent. Treatment is intended for patients with superficial varicose veins of the legs that cause symptoms. The sterile kit is made up of an adhesive, a specially formulated n-butyl-2-cyanoacrylate, and delivery system components that include a catheter, guide wire, dispenser gun, dispenser tips, and syringes. Treatment can be performed in an office or outpatient setting. A trained healthcare professional inserts the catheter through the skin into the diseased vein to allow injection of the adhesive, a clear liquid that polymerizes into solid material. The healthcare professional monitors proper placement of the catheter using ultrasound imaging during delivery of the adhesive into the diseased vein to seal it. Because the VenaSeal™ system does not incorporate heat application or cutting, patients experience less bruising and can promptly return to their normal activities.
Dermal filler with calcium hydroxylapatite (CaHA) + integral 0.3% lidocaine
In March 2015, the FDA approved Radiesse® (+) injectable implant dermal filler that contains a small quantity of the local anesthetic lidocaine. Radiesse® (+) is indicated for subdermal implantation for the correction of moderate to severe facial wrinkles and folds, such as nasolabial folds. This new preparation enhances patient comfort and eliminates the need for in-office lidocaine mixing.
Dalbavancin for IV injection
In March 2015, the European Commission approved dalbavancin, a novel second-generation lipoglycopeptide antibiotic, for the treatment of adults with skin infections. Treatment is indicated for acute bacterial skin and skin structure infections (ABSSSI) caused by designated susceptible strains of Gram-positive microorganisms, such as Staphylococcus aureus (including methicillin-susceptible and methicillin-resistant strains) and Streptococcus pyogenes. To reduce the development of drug-resistant bacteria and maintain its efficacy, use should be limited to the treatment of infections that are proven or strongly suspected to be caused by susceptible bacteria. This drug is marketed in the US under the trade name Dalvance®.
Pembrolizumab for IV infusion
The United Kingdom’s Medicines and Healthcare Products Regulatory Agency cleared pembrolizumab for early access in March 2015 to treat adults and children ≥12 years of age with advanced melanoma. Treatment is indicated for 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. Pembrolizumab is the first treatment to be accepted under the UK’s new Early Access to Medicines Scheme (EAMS), which is similar to the US FDA’s Breakthrough Therapy Designation for accelerated drug approval.