Allergan plc announced today the U.S. Food and Drug Administration's (FDA) approval of TEFLARO (ceftaroline fosamil) for use in pediatric patients.
The IV medication is approved for patients ages two months to 18 years to treat acute bacterial skin and skin structure infections (AFSSSI) and community-acquired bacterial pneumonia (CABP).
"The impact of ABSSSI and CABP among children is significant, as these infections often require hospitalization and are met with limited pediatric treatment options, particularly as resistance increases among the pathogens that cause these infections," Allergan Chief R&D Officer David Nicholson said. "These new indications are yet another testament to our ongoing research and development in anti-infectives to address the evolving challenges of serious infections. Importantly, it allows us to educate physicians on the data they need to prescribe TEFLARO to appropriate pediatric patients in need of an option that is safe and effective against some of the most difficult-to-treat pathogens in ABSSSI and CABP."
TEFLARO was tested for its effectiveness against ABSSSI and CABP in children, including infections caused by Staphylococcus aureus (MRSA), Streptococcus pneumoniae and other bacteria. The studies found that TEFLARO produced an 80.4 percent response by the third day of treatment in the ABSSSI study. The clinical cure rate was 94.4 percent when tested eight to 15 days after the end of treatment.
In the CABP trial, patients treated with TEFLARO responded at a rate of 69.2 percent by the fourth day of the study. The clinical cure rate was 87.9 percent.