FDA approves delafloxacin for serious skin infections
The FDA has approved delafloxacin (Baxdela) for the treatment of acute bacterial skin and skin structure infections caused by susceptible isolates of the following:
* Gram-positive organisms: Staphylococcus aureus (including MRSA and methicillin-susceptible isolates), Staphylococcus haemolyticus, Staphylococcus lugdunensis, Streptococcus agalactiae, Streptococcus anginosus group (including Streptococcus anginosus, Streptococcus intermedius, and Streptococcus constellatus), Streptococcus pyogenes, and Enterococcus faecalis.
* Gram-negative organisms: Escherichia coli, Enterobacter cloacae, Klebsiella pneumoniae, and Pseudomonas aeruginosa.
Delafloxacin is available orally and as an I.V. infusion. The oral tablet can be given without regard to food and must be given at least 2 hours before or 6 hours after antacids containing magnesium, or aluminum, with sucralfate, with metal cations such as iron, or with multivitamin preparations containing zinc or iron, or with didanosine buffered tablets for oral suspension use or the pediatric powder for oral solution. Do not administer any other medications or any solution that contains multivalent cations, such as calcium and magnesium, through the same I.V. line as the delafloxacin I.V. infusion. Dose adjustments are required for patients with kidney impairment based on the estimated glomerular filtration rate.
Delafloxacin is contraindicated in patients with known hypersensitivity to delafloxacin or any of the fluoroquinolone class of antibacterial drugs.
Betrixaban now available for VTE in adults
The FDA has approved betrixaban (Bevyxxa) for the prophylaxis of venous thromboembolism (VTE) in adult patients hospitalized for an acute medical illness who are at risk for thromboembolic complications due to moderate or severe restricted mobility and other risk factors for VTE. Betrixaban is an oral, once-daily factor Xa inhibitor approved for hospital and extended-duration prevention (35 to 42 days) of VTE in acutely ill patients.
The FDA's approval was based on data from the Acute Medically Ill VTE Prevention with Extended Duration Betrixaban (APEX) multinational clinical trial comparing extended-duration betrixaban to short-duration of enoxaparin in the prevention of VTE in an acutely medically ill hospitalized population with risk factors for VTE. Fewer DVT and PE events were observed with betrixaban compared with those taking enoxaparin (4.4% versus 6.0%; relative risk 0.75, 95% confidence interval) with no significant increase in major bleeding (0.67% versus 0.57%). In these studies, the most frequent reason for treatment discontinuation was bleeding, with an incidence rate for all bleeding episodes of 2.4% and 1.2% for betrixaban and enoxaparin, respectively.
Drug approved for hepatitis C genotypes 1-6
The FDA has approved Mavyret (glecaprevir and pibrentasvir) for the treatment of adults with chronic hepatitis C virus (HCV) genotypes 1-6 without cirrhosis or with mild cirrhosis, including patients with moderate-to-severe kidney disease and those on dialysis. It is also approved for adults with HCV genotype 1 infection who have been previously treated with a regimen either containing an NS5A inhibitor or an NS3/4A protease inhibitor but not both.
Mavyret is the first treatment with an 8-week duration approved for all HCV genotypes 1-6 in adult patients without cirrhosis who have not been previously treated. Treatment duration with Mavyret differs depending upon treatment history, viral genotype, and cirrhosis status.
In clinical trials, the safety and efficacy of Mavyret were evaluated in approximately 2,300 adults with genotype 1, 2, 3, 4, 5, or 6 HCV infection without cirrhosis or with mild cirrhosis. The trials showed that 92% to 100% of patients who received Mavyret for 8, 12, or 16 weeks had no virus detected in the blood 12 weeks after finishing treatment, suggesting that the patients' infections had been cured.
The most common adverse reactions in patients taking Mavyret were headache, fatigue, and nausea. The drug is not recommended in patients with moderate cirrhosis and is contraindicated in patients with severe cirrhosis and in patients taking atazanavir and rifampin.