Arrevus Drug Gets Second Nod from FDA in Less Than a Month

Raleigh-based biotechnology company Arrevus has received a second show of support from the Food and Drug Administration for its new medicine to treat cystic fibrosis (CF).

The FDA has granted Orphan Drug Designation to ARV-1801, Arrevus’ sodium fusidate oral antibiotic. The investigational product is highly active against antibiotic-resistant strains of MRSA, a tough-to-treat staph infection common among CF patients.

The FDA designation can speed up market approval. It also opens the door to orphan drug grants, tax credits and – potentially – seven years of market exclusivity. Orphan drug status is awarded to clinical-stage therapies that target conditions affecting fewer than 200,000 people in the United States.

The FDA also granted Qualified Infectious Disease Product (QIDP) status to ARV-1801 in January to treat pulmonary exacerbations in CF patients. These episodes decrease lung function and increase the risk of death over time. Currently there are no approved therapies, and Arrevus is planning a phase 2 clinical study to gauge the effectiveness of ARV-1801 in managing the condition.

QUIP encourages the development of new antibiotics to treat serious or life-threatening infections. The designation can mean an extended period of market exclusivity. 

The North Carolina Biotechnology Center supported the company’s development of ARV-1801 with a $250,000 Small Business Research Loan in 2019.

“Cystic fibrosis patients have limited oral options to treat the frequent infections they encounter,” said Carl N. Kraus, M.D., president and CEO of Arrevus. “We are thrilled to have the FDA’s support and we will continue our efforts to bring ARV-1801 to cystic fibrosis patients.”

“At the end of the day, what drives disease progression and kills people with cystic fibrosis are infections that become resistant to currently available anti-infective treatments,” added Emily Kramer-Golinkoff. She is a CF sufferer who co-founded Emily’s Entourage, a nonprofit organization that raises money and awareness to help find a cure for rare mutations of cystic fibrosis. 

“As our disease advances, we run out of antimicrobial tools to treat the infections ravaging our lungs,” she said. “We are in dire need of new oral and inhaled anti-infective treatments, particularly for certain pathogens for which we have limited...antibiotics to treat, including MRSA.”

The ability of sodium fusidate to wipe out MRSA in CF patients is well established outside the United States, according to Arrevus. In the UK and Australia, it is used as a first line treatment to rid patients of the bacterium. And it is the only member of the fusidane class of antibiotics available globally. But it isn’t yet approved or marketed in this country, where cystic fibrosis affects approximately 30,000 people who normally live only to their mid-to-late 30s.

Arrevus, founded in 2015, develops novel medicines that address unmet medical needs in conditions with high treatment failure rates, few therapeutic options and serious outcomes.