FDA Approvals Roundup
A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).New approvals
Bronchitol inhalation powder okayed as add-on therapy for cystic fibrosis
Chiesi USA’s Bronchitol (mannitol, oral inhalation dry powder) has been approved as an add-on maintenance therapy for improving pulmonary function in patients aged 18 years or older with cystic fibrosis.
Approval of Bronchitol was based on findings from three 26-week, randomized, double-blind, controlled clinical trials involving 761 patients with cystic fibrosis. Findings showed that patients receiving the study drug had a statistically significant improvement in forced expiratory volume at 26 weeks after baseline compared with control patients.
Patients have to be tested and evaluated for tolerance of the therapy before it can be prescribed for use.
Cystic fibrosis is a genetic disorder that damages body organs, such as the lungs and digestive system. A genetic defect causes cell secretions to become less mucous and sticky, resulting in difficulties with breathing and inflammation of the pancreas.
New indications
Selzentry labeling now includes new data for pediatric patients
Viiv Healthcare’s Selzentry (maraviroc, 20 mg/mL oral solution) has received approval for label changes to reflect new safety and pharmacokinetic data for babies weighing 2 kg or more who are infected with HIV.
The therapy is currently approved for use with other antiretroviral agents (ARVs) for treating adult and pediatric patients weighing at least 2 kg with CCR5 tropic human immunodeficiency virus type 1 (HIV-1) infection. It is not recommended for use in in preterm neonates or infants weighing less than 2 kg.
The labeling approval covers new weight-based dosages for Selzentry tablets for pediatric patients aged 2 years or older, who weigh 10 kg and have normal renal function. It also covers weight-based dosages for the oral solution in babies weighing 2 kg or more.
In regard to safety, the revised label includes new information from the IMPAACT P2007 trial relating to adverse reactions in full-term, HIV-1–exposed babies who received Selzentry in combination with other ARVs, either as two single doses within two weeks of birth, or twice daily for six weeks. The infants were followed for safety evaluation for 16 weeks. Observed adverse reactions were mild to moderate, and there were no additional reactions compared with those seen in adults. The study findings also showed that pharmacokinetic parameters for the drug were similar to those seen in adults.