FDA Actions
The FDA has removed the black box warning from varenicline (Chantix), the popular smoking cessation drug. The black box label warned of neuropsychiatric events such as depression and suicidality. But the results of a large clinical trial suggest the effects on mood are less than expected. The FDA also revised labeling for bupropion (Zyban), also used for smoking cessation. Bupropion’s boxed warning no longer contains language describing serious mental health side effects, although information about the risk remains in the warnings sections of both drugs.
The FDA has approved crisaborole ointment for the treatment of moderate eczema (atopic dermatitis) in patients ≥ 2 years of age. The new ointment is a PDE-4 inhibitor, although its mechanism of action in treating atopic dermatitis is unknown. Safety and efficacy were based on two placebo-controlled trials of more than 1,500 patients suffering from mild to moderate atopic dermatitis in which the cream achieved greater response with clear or almost clear skin at 28 days. Crisaborole ointment is marketed as Eucrisa.
The FDA has approved nusinersen to treat spinal muscular atrophy (SMA) in children and adults. SMA is a rare and often fatal genetic disease that in its most severe form kills children before age 2 years. The drug is administered intrathecally several times a year. Efficacy was demonstrated in a randomized trial of 121 children presenting with infantile-onset SMA in which 40% of patients achieved improvement in motor milestones. According to the agency, a later uncontrolled trial in older children “appeared generally supportive of the clinical efficacy ....” Side effects include upper respiratory infections, lower respiratory infections, and constipation. The FDA granted this application fast track and orphan drug designation as well as priority review. Nusinersen is marketed as Spinraza. The drug has come under intense scrutiny, including an article in The New York Times, because of Biogen’s pricing strategy, which will make the drug one of the most expensive on the market. The first year of therapy is expected to cost up to $750,000, with subsequent costs of about $375,000 per year.
The FDA has concluded that pioglitazone (Actos) may be linked to an increased risk of bladder cancer. The drug label already contains language about the risk, but the FDA is updating the warning based on an updated review. The new warning recommends that pioglitazone should not be prescribed to those suffering from active bladder cancer, and caution should be used in patients with a history of bladder cancer. Patients on pioglitazone should be warned to look for hematuria, urgency, or dysuria.
The FDA has approved a new indication for empagliflozin (Jardiance) to reduce the risk of cardiovascular death in adult patients presenting with type 2 diabetes and cardiovascular disease. Empagliflozin is an SGLT2 inhibitor that facilitates excretion of glucose through the kidney. The new indication was based on the EMPA-REG OUTCOME trial, which showed high-risk patients demonstrated a 38% relative risk reduction in rate of death compared to placebo patients.
In this section: FDA removes black box warning from popular smoking cessation drug, approves treatment for young eczema patients, greenlights drug for spinal muscular atrophy, and links a drug to higher bladder cancer risk.
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