Vapendavir for the treatment of rhinovirus infection in adults with chronic obstructive pulmonary disease.
Physician-requested expanded access for individual patients on a case-by-case basis when specific criteria are met:
The patient has a serious or immediately life-threatening disease for which no alternative therapies are currently available.
The expanded access program is authorized for the requested indication.
There is adequate clinical evidence of a positive benefit to risk profile for the investigational medicine in the disease indication, suggesting that a clinically meaningful benefit may be expected and that the benefits outweigh any potential risks.
Providing investigational medicine through expanded access will not compromise clinical trials or the regulatory pathway.
Patient is not eligible for participation in an open/ongoing Altesa therapeutic trial with the investigative agent (the patient’s location relative to a participating trial site is not considered as part of trial eligibility)