In a mixed vote, an FDA advisory committee has voted to remove the black box warning from varenicline (Chantix). The warning was placed in 2009 after the FDA received reports of neuropsychiatric events, including depression and thoughts of suicide. But a company-funded trial published in April did not show a significant increase in neuropsychiatric adverse events attributable to varenicline or bupropion relative to nicotine patch or placebo (http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(16)30272-0/abstract). Although some at the FDA criticized the study design, 10 of the 19 committee members voted to remove the warning. Of the dissenters, several voted to amend the current warning, while others voted to keep the current warning as is. This is the second time varenicline’s manufacturer has petitioned the FDA to remove the warning, after an unsuccessful attempt in 2014.
The FDA has approved the first biosimilar to adalimumab (Humira). Adalimumab-atto is approved for the same indications as adalimumab, including rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, plaque psoriasis, and juvenile idiopathic arthritis in children ≥ 4 years of age. The approval was based on structural and functional characterization, animal study data, human pharmacokinetic and pharmacodynamics data, clinical immunogenicity data, and other clinical safety and effectiveness data that demonstrate adalimumab-atto is biosimilar to adalimumab. Adalimumab-atto is marketed as Amjevita.
The FDA has issued a warning regarding direct-acting antiviral drugs used to treat hepatitis C (HCV) and the risk of reactivation of hepatitis B (HBV) in patients co-infected with HBV and HCV. The FDA has identified 24 cases of HBV reactivation in the last three years, of which two patients died and one required a liver transplant. The drugs implicated include the most commonly used HCV drugs, including (by tradename) Harvoni, Sovaldi, Daklinza, Viekira Pak, and Zepatier. The FDA recommends testing patients for HBV prior to initiating therapy for HCV, and monitoring patients for HBV reactivation during and after treatment. The FDA also added a boxed warning to all direct-acting antivirals to treat HCV warning about HBV reactivation.
In a controversial decision, the FDA has approved the first drug to treat the most common childhood form of muscular dystrophy. Eteplirsen has been the subject of intense lobbying by patient advocacy groups for years, but evidence for effectiveness has been marginal. Approval was based on one study of 12 boys with Duchenne muscular dystrophy, of whom all were treated (no control group). The approval also was based on a surrogate endpoint without evidence of improvement in motor function. The drug was not recommended for approval by the agency’s expert panel, but the FDA overruled that decision and approved the drug on a close vote. The drug also was granted fast-track approval and orphan designation, which is used to accelerate approval and provide financial incentives to companies to develop drugs for rare conditions. Eteplirsen is marketed as Exondys 51. Eteplirsen is expected to cost about $300,000 per year.
In this section: FDA removes black box warning from Chantix; approves first biosimilar to Humira; issues warning about hepatitis C drug; and green lights first drug to treat common childhood form of muscular dystrophy.
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