Drug News

Adalimumab-bwwd for SC injection

Trade Name: Hadlima™
Company: Samsung Bioepis

Approval Dates/Comments: The US FDA approved adalimumab-bwwd, an anti-tumor necrosis factor biosimilar referencing Humira® (adalimumab), in July 2019 for treating multiple indications including plaque psoriasis and psoriatic arthritis. This drug will not be commercially available in the US until June 30, 2023.

Apremilast tablets

Trade Name: Otezla®
Company: Celgene

Approval Dates/Comments: In July 2019, the FDA approved an expanded label for apremilast, a selective inhibitor of phosphodiesterase 4, to include the treatment of oral ulcers associated with Behçet’s Disease, making this the drug’s third indication in addition to plaque psoriasis and psoriatic arthritis. This marks the first and only approved treatment option for oral ulcers associated with Behçet’s Disease.

Calcipotriene + betamethasone dipropionate

Trade Name: Enstilar® foam Taclonex® topical suspension
Company: Leo Pharma

Approval Dates/Comments: In July 2019, the FDA expanded the approved indication for Enstilar® foam for the topical treatment of plaque psoriasis to include patients aged ≥12 years. This combination product contains calcipotriene 0.005% (vitamin D analog) and betamethasone dipropionate 0.064% (corticosteroid). Additionally, the FDA approved Taclonex® topical suspension for treating scalp and body plaque psoriasis in patients aged ≥12 years.

Bempegaldesleukin + nivolumab for IV use

Trade Name: NKTR-214 + Opdivo®
Company: Nektar Therapeutics Bristol-Myers Squibb

Approval Dates/Comments: In August 2019, the FDA granted Breakthrough Therapy designation to bempegaldesleukin in combination with nivolumab for first-line treatment of unresectable or metastatic melanoma. Bempegaldesleukin is an investigational CD122-preferential interleukin (IL)-2 pathway agonist and nivolumab is a programmed cell death protein 1 (PD-1) immune checkpoint inhibitor. Bempegaldesleukin was designed to elicit activation and proliferation of cancer-killing immune cells, CD8+ effector T cells and natural killer (NK) cells.

Dupilumab for SC injection

Trade Name: Dupixent®
Company: Sanofi/Regeneron

Approval Dates/Comments: The European Commission approved dupilumab in August 2019 for treating patients aged 12-17 years with moderate-to-severe atopic dermatitis (AD) who are candidates for systemic therapy. Dupilumab is now the first biologic agent approved in the European Union to treat adolescent AD patients.

Device News

Magnetic muscle stimulation for body contouring

Trade Name: CoolTone™
Company: Allergan plc

Approval Dates/Comments: In June 2019, FDA clearance was granted for CoolTone™ for improvement of abdominal tone, strengthening of the abdominal muscles, and development for firmer abdomen. CoolTone™ is also indicated for strengthening, toning and firming of buttocks and thighs. Using magnetic muscle stimulation, CoolTone™ technology penetrates into the muscle layers and induces involuntary muscle contractions. The body responds to these contractions by strengthening its muscle fibers, resulting in improved muscle conditioning.

Laser device for body contouring

Trade Name: eon™ FR
Company: Dominion Aesthetic Technologies

Approval Dates/Comments: FDA 510(k) clearance was granted in June 2019 for eon™ FR (fat reduction) laser, which is a non-contact medical device that reduces fat. The laser energy is delivered using a patent-pending powered articulated arm. The Eon™ FR (1064 nm laser) is intended for non-invasive lipolysis of the abdomen to disrupt adipocyte cells in patients with a body mass index of ≤30.

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