FDA Grants Fast Track Designation to Apnimed Sleep Apnea Drug Candidate AD109
The US FDA has granted Fast Track designation for Apnimed’s oral pharmacologic AD109 for the treatment of obstructive sleep apnea (OSA).
“Fast Track designation is a significant milestone in the development of AD109 and provides an accelerated regulatory pathway that recognizes the urgent need for new pharmacologic treatments for OSA that are easier for people to tolerate,” says Larry Miller, MD, Apnimed CEO.“Currently the vast majority of more than 35 million Americans who have OSA remain untreated despite the potential for serious health risks associated with the condition, including cardiovascular disease and diabetes. We will continue to work closely with the FDA to support the development and review of AD109 beginning with the trial design for our Phase 3 program, which we anticipate initiating at the end of 2022.”
Regulatory Pathway and Mechanism
FDA’s Fast Track designation is intended to facilitate the development and expedite the review of new drugs to treat serious conditions and that fill an unmet medical need.The benefits of Fast Track designation include opportunities for frequent meetings with the FDA to discuss development plans, trial design, and data needed to support drug approval, as well as the ability to submit a New Drug Application on a rolling basis, and eligibility for priority review, if relevant criteria are met.
Apnimed’s AD109 has the potential to be the first oral pharmacologic that treats OSA airway obstruction at night.It is a first-in-class, novel, investigational combination dosed once daily at bedtime and is designed to treat OSA patients across a broad spectrum of disease severity.AD109 is a combination of the selective norepinephrine reuptake inhibitor Atomoxetine (HY-107370) and the antimuscarinic agent Aroxybutynin (HY-B0267C).AD109 shows orally active significantly and reduces the apnea-hypopnea index.
Sleep Disordered Breathing and Heart Health
An estimated 25% of people who use a pacemaker to maintain a regular heart rhythm also have sleep apnea.This suggests there may be a close relationship between sleep apnea and arrhythmias.Treating sleep apnea has also helped reverse or reduce the incidence of arrhythmias, which means that sleep apnea is a likely cause of arrhythmia in some people.
People with heart disease also experience sleep apnea in greater proportions.This means it’s likely that some people with sleep apnea may have already had some heart problems.Sleep apnea can worsen this damage which can further increase someone’s risk of abnormal heart rhythms.
