Dermatology

FDA: First Treatment for Hidradenitis Suppurativa Approved, SGLT2 Inhibitor Fracture Warnings Strengthened

Adalimumab – Hidradenitis Suppurativa1

The FDA has approved Humira (adalimumab), the first FDA-approved treatment option for moderate to severe hidradenitis suppurativa (HS) after granting the drug orphan status earlier this year. Adalimumab is the first and only drug approved by the FDA for the treatment of this condition.

HS is a chronic inflammatory skin disease characterized by nodules and abscesses located in the armpit, groin, buttocks, and under the breasts. Other treatments for the condition include surgical excision of affected areas of the skin and antibiotic treatment for possible associated infections. Diagnosis is often delayed, despite the importance of managing the disease early. 
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The approval was based on 2 Phase 3 studies (PIONEER I and PIONEER II) of 633 individuals with moderate to severe HS randomly assigned either adalimumab or placebo. In both trials, more patients given adalimumab saw reductions in the total number of abscesses than those taking placebo.

Common side effects of adalimumab include upper respiratory infections, headache, rash, and nausea.

Humira is also indicated for use in patients with severe rheumatoid arthritis, polyarticular juvelile idiopathic arthritis, psoriatic arthritis, Ankylosing spondylitis, Crohn's disease, ulcerative colitis, and chronic plaque psoriasis.

Fracture Risk with Conagliflozin2

The FDA has strengthened the warning of bone fractures associated with the use of the type 2 diabetes drug canagliflozin. A new Warning and Precaution and revised Adverse Reactions section on the drug’s label will reflect these changes.

Other drugs in the SGLT2 inhibitor class, including dapagliflozin and empagliflozin will also be evaluated.

The new warning comes in response to reports of fractures as early as 12 weeks after starting canagliflozin—which has been linked to decreases in bone mineral density—and have been caused by low-trauma events.

“Health care professionals should consider factors that contribute to fracture risk prior to starting patients on canagliflozin,” the FDA recommended.

Uridine Triacetate – Hereditary Orotic Aciduria3

The FDA has approved Xuriden (uridine triacetate) for the treatment of patients with hereditary orotic aciduria, a rare metabolic disorder.

The drug, taken orally by mixing with food or milk, is intended to replace uridine, a component of ribonucleic acid that those with the disorder are unable to synthesize.

The safety and efficacy of uridine triacetate were evaluated in a 6-week, open-label trial of 4 patients with hereditary orotic aciduria. At both 6 weeks and 6 months, uridine triacetate resulted in stability of hematologic parameters in all participants.

No side effects were observed.

References:

  1. Abbvie. AbbVie's HUMIRA® (Adalimumab) receives first and only US Food and Drug Administration approval for moderate to severe hidradenitis suppurativa [press release]. September 10, 2015.
  2. FDA. Invokana and Invokamet (canagliflozin): drug safety communication - new information on bone fracture risk and decreased bone mineral density [press release]. September 10, 2015. http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm461876.htm.
  3. FDA. FDA approves new orphan drug to treat rare autosomal recessive disorder [press release]. September 4, 2015. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm457867.htm.