Delafloxacin for adults with community-acquired bacterial pneumonia
The FDA has approved delafloxacin (Baxdela) for the treatment of adult patients with community-acquired bacterial pneumonia caused by designated susceptible bacteria. The fluoroquinolone was approved in 2017 for the treatment of adult patients with acute bacterial skin and skin structure infections caused by designated susceptible bacteria.
The latest approval was based on positive results from a Phase 3 randomized, double-blind trial comparing the safety and efficacy of delafloxacin to moxifloxacin. Delafloxacin met all key primary and secondary endpoints in the trial as well as the secondary endpoint of statistical noninferiority compared with moxifloxacin. Data further showed that I.V./oral delafloxacin successfully eradicated key respiratory pathogens at rates comparable to moxifloxacin.
Both I.V. and oral delafloxacin were well tolerated among study participants. Overall, adverse reaction rates were similar between treatment arms. The most common adverse reactions reported in the delafloxacin treatment arm included diarrhea and transaminase increases, which were generally mild and did not lead routinely to treatment discontinuation.
Delafloxacin is a product of Melinta Therapeutics.
FDA approves canagliflozin to reduce risk of diabetic kidney disease
The FDA approved canagliflozin (Invokana) to reduce the risk of end-stage kidney disease, worsening kidney function, cardiovascular death, and heart failure hospitalization in adults with type 2 diabetes mellitus (T2DM) and diabetic kidney disease.
The new indication is based on results of the landmark CREDENCE trial that targeted patients with significant chronic kidney disease, a group typically excluded from clinical trials. In the trial, canagliflozin was associated with a 30% reduction in the risk of the primary composite endpoint (end-stage kidney disease, doubling of serum creatinine, and renal or cardiovascular death). Canagliflozin also reduced the risk of secondary cardiovascular endpoints, including a 39% reduction in the risk of hospitalization for heart failure.
Canagliflozin was first approved for the treatment of T2DM in 2013; an expanded indication in 2018 reduced the risk of major adverse cardiovascular reactions in adults with T2DM who had established cardiovascular disease.
Canagliflozin is a product of Janssen.
FDA approves new migraine treatment
The FDA-approved lasmiditan (Reyvow) tablets for the acute treatment of migraine with or without aura in adults. Lasmiditan is not approved for preventive treatment of migraine. The medication's effectiveness for the acute treatment of migraine was demonstrated in two randomized, double-blind, placebo-controlled trials involving 3,177 adults with a history of migraine with and without aura. The percentages of patients whose pain resolved and whose most bothersome migraine symptoms resolved 2 hours after treatment were significantly greater among patients who received lasmiditan at all doses compared with those who took placebo.
The most common adverse reactions reported by patients who took lasmiditan in the clinical trials included dizziness, fatigue, paresthesia, and sedation. Lasmiditan causes central nervous system (CNS) depression, including dizziness and sedation, and should be used with caution if taken in combination with alcohol or other CNS depressants. There is a risk of driving impairment while taking lasmiditan, so patients are advised not to drive or operate machinery for at least 8 hours after taking the drug. Patients who cannot follow this advice are advised not to take lasmiditan.
Lasmiditan is a product of Eli Lilly and Company.