Novartis drug Afinitor DISPERZ® receives FDA approval to treat TSC-associated partial-onset seizures
Summary
"We are pleased that this latest approval for Afinitor DISPERZ in the US will make an important difference to patients with tuberous sclerosis complex who experience partial-onset seizures, one of the most debilitating manifestations of TSC," said Ameet Mallik, Executive Vice President, Novartis Oncology US.The most common all-grade adverse events of any cause reported during the core phase at frequencies > 15% in the Afinitor DISPERZ LE/HE arms included stomatitis, diarrhea, nasopharyngitis, upper respiratory tract infection, and pyrexia 4 .The most frequent (≥10%) all grade adverse events (AEs), of any cause, reported with Afinitor LE/HE vs placebo included stomatitis (54.7%/63.8% vs 9.2%), diarrhea (17.1%/21.5% vs 5.0%), nasopharyngitis (13.7%/16.2% vs 16.0%), upper respiratory tract infection (12.8%/15.4% vs 12.6%), pyrexia (fever) (19.7%/13.8% vs 5.0%), vomiting (12.0%/10.0% vs 9.2%), cough (11.1%/10.0% vs 3.4%), and rash (6.0%/10.0% vs 2.5%).Patients should contact their healthcare provider or get medical help right away if they get signs and symptoms of a severe allergic reaction including: rash, itching, hives, flushing, trouble breathing or swallowing, chest pain or dizziness.Related Links EAST HANOVER, N.J., April 10, 2018 /PRNewswire/ --Novartis today announced that the US Food and Drug Administration (FDA) has approved Afinitor DISPERZ ® (everolimus tablets for oral suspension), for the adjunctive treatment of adult and pediatric patients aged two years and older with tuberous sclerosis complex (TSC)-associated partial-onset seizures.