Name/CompanyApproval Dates and Comments
Onabotulinum-toxinA for injection
Botox® Cosmetic
Allergan plc
The US FDA approved onabotulinumtoxinA for its third indication in October 2017 for the temporary improvement in the appearance of moderate to severe forehead lines associated with frontalis muscle activity in adults. This is the only neurotoxin indicated to treat three facial areas – forehead lines, crow’s feet lines, and glabellar lines.
Hyaluronic acid dermal filler
Restylane® Silk
In October 2017, the FDA approved the use of a small blunt tip cannula with Restylane® Silk for lip augmentation. Restylane® Silk was the first FDA-approved hyaluronic acid (HA) dermal filler specifically designed for lip augmentation and the smoothing of
wrinkles around the mouth in patients aged ≥21 years, and it is now the first HA dermal filler to be approved for lip injection via cannula.
Ustekinumab for SC injection
Janssen Biotech
The FDA approved an expanded indication for ustekinumab in October 2017 for the treatment of adolescents aged ≥12 years with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy. The approval of ustekinumab for
this expanded indication was based on data from a Phase 3 study that showed at least two-thirds of patients ≥12 years of age who received the drug were responders at the week 12 primary endpoint after two doses at weeks 0 and 4.
Golimumab for IV infusion
Simponi Aria®
Janssen Biotech
In October 2017, the FDA approved golimumab, the only fully-human anti-tumor necrosis factor (TNF)-alpha therapy administered via a 30-minute intravenous (IV) infusion, for the treatment of adults with active psoriatic arthritis (PsA) or active ankylosing spondylitis (AS). The PsA and AS approvals are based on two large-scale, pivotal Phase 3 studies involving more than 600
patients. In the GO-VIBRANT (PsA) study, 75% of patients receiving golimumab, compared with 22% of placebo (P<0.001), achieved at least a 20% improvement in the American College of Rheumatology (ACR20) response at week 14. Treatment with golimumab resulted in inhibition of the progression of structural joint damage and improvement in physical function associated with PsA at week 24.
Herpes zoster vaccine (non-live recombinant, AS01B adjuvanted) suspension for IM injection
In October 2017, both Health Canada and the US FDA approved Shingrix, a non-live, recombinant subunit vaccine for the prevention of herpes zoster (shingles) in adults aged ≥50 years. Shingrix is administered intramuscularly (IM) in two doses. Approval was based
on Phase 3 trials that evaluated efficacy, safety, and immunogenicity in more than 38,000 subjects. In a pooled analysis of these studies, Shingrix demonstrated efficacy against herpes zoster greater than 90% across all age groups, as well as sustained efficacy over a 4-year
follow-up period.
Brentuximab vedotin for IV infusion
Seattle Genetics
The FDA approved brentuximab vedotin in November 2017 for the treatment of adults with primary cutaneous anaplastic large cell lymphoma (pcALCL) or CD30-expressing mycosis fungoides (MF) who have received prior systemic therapy. Approval was based on a 56% objective response rate for brentuximab vedotin vs. 12% for physician’s choice in a Phase 3 trial (ALCANZA) of 131 patients with MF or pcALCL. All patients had received one prior systemic therapy and were randomized (1:1) to receive either brentuximab vedotin or the physician’s choice of methotrexate or bexarotene. Complete response in the brentuximab vedotin arm was 16% vs. 2% in the physician’s choice arm (P=0.007). Median progression-free survival was 17 months in the brentuximab vedotin arm vs. 4 months in the physician’s choice arm.

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