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Update on Drugs and Drug News: March-April 2016


Name/Company Approval Dates and Comments

Betamethasone valerate topical patch
Beteflam™
Cipher
Pharmaceuticals

In December 2015, Health Canada approved a betamethasone valerate topical patch for the treatment of mild to moderate plaque psoriasis of the elbows and knees for a maximum duration of 30 days in adult patients. This novel self-adhesive medicated plaster contains 0.1% betamethasone valerate. The patch is applied once- daily to the affected region.

Human papillomavirus (HPV) 9-valent vaccine, recombinant
Gardasil®9
Merck

The US FDA approved an expanded age indication for GARDASIL®9 in December 2015 to include use in males 16 to 26 years of age, for the prevention of anal cancer caused by HPV types 16, 18, 31, 33, 45, 52 and 58, precancerous or dysplastic lesions caused by HPV types 6, 11, 16, 18, 31, 33, 45, 52 and 58, and genital warts caused by HPV types 6 and 11. GARDASIL®9 is already approved for use in boys 9 to 15 years of age for the prevention of these diseases.

Talimogene laherparepvec (T-Vec) intralesional injection
Imlygic®
Amgen Inc.

The European Commission (EC) approved talimogene laherparepvec (the first viral-based cancer therapeutic) in December 2015 for the treatment of adults with unresectable melanoma that is regionally or distantly metastatic (Stage IIIB, IIIC and IVM1a), with no bone, brain, lung or other visceral disease.

Pembrolizumab IV injection
Keytruda®
Merck & Co., Inc.

The FDA approved an expanded indication for pembrolizumab (anti-PD-1 programmed death receptor-1) therapy in December 2015 to include the first-line treatment of patients with unresectable or metastatic melanoma. This approval marks the second FDA- approved indication in advanced melanoma for Keytruda®, which is now the first anti-PD-1 therapy approved for previously untreated advanced melanoma patients regardless of BRAF status.

Adalimumab SC injection
Humira®
AbbVie Inc.

Health Canada approved adalimumab in January 2016 for the treatment of adults with active moderate to severe hidradenitis suppurativa (acne inversa), who have not responded to conventional therapy, including systemic antibiotics.

Secukinumab SC injection
Cosentyx®
Novartis AG

In January 2016, the FDA expanded its approval of secukinumab to include two new indications - the treatment of adult patients with active psoriatic arthritis and active ankylosing spondylitis. Secukinumab is a monoclonal antibody that inhibits IL-17A - elevated levels of this cytokine are associated with inflammatory diseases.

Ustekinumab SC injection
Stelara®
Janssen Inc.

In January 2016, Health Canada approved ustekinumab, a fully human interleukin (IL)-12 and IL-23 antagonist, for the treatment of chronic moderate to severe plaque psoriasis in adolescent patients aged 12 to 17 years who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies. This marks the first biologic to gain regulatory approval for the treatment of moderate to severe psoriasis in adolescents.

Nivolumab + ipilimumab
Opdivo® + Yervoy®
Bristol-Myers Squibb Company

In January 2016, expanded FDA approval was granted to nivolumab in combination with ipilimumab for the treatment of patients with BRAF V600 wild-type and BRAF V600 mutation-positive unresectable or metastatic melanoma. This approval expands the original indication for the Opdivo® + Yervoy® regimen for treating patients with BRAF V600 wild-type unresectable or metastatic melanoma to include patients regardless of BRAF mutational status.

Erratum: Due to an editing error, the incorrect US FDA approval date of November 2016 for dabrafenib + trametinib (Tafinlar® + Mekinist®, Novartis AG) was inadvertently published in Skin Therapy Letter 2016 Jan- Feb;21(1):12. The correct approval date is November 2015. The publisher apologizes for any inconvenience.


In this issue:

  1. Dupilumab, A Monoclonal Antibody for Atopic Dermatitis: A Review of Current Literature
  2. Nivolumab for Metastatic Melanoma
  3. Skin Treatments Introduced in 2015
  4. Update on Drugs and Drug News - March-April 2016