Date: 2017-11-13
Type of information: Submission of a Market Application in the US
Product name: revefenacin (TD-4208)
Compound: revefenacin
Therapeutic area: Lung diseases - Respiratory diseases
Action mechanism:
- long-acting muscarinic antagonist (LAMA).
- Revefenacin is an investigational long-acting muscarinic antagonist (LAMA) and a proposed once-daily, nebulized bronchodilator in development for the treatment of chronic obstructive pulmonary disease (COPD).
- Theravance Biopharma and its affiliates have partnered with Mylan and its affiliates on the development and commercialization of nebulized revefenacin products for COPD and other respiratory diseases. The companies are developing revefenacin as a once-daily, nebulized bronchodilator for the treatment of patients with COPD that will be compatible with a range of jet nebulizers.
Company: Mylan (USA - PA) Theravance (UK)
Disease: chronic obstructive pulmonary disease (COPD)
Latest news:
- • On November 13, 2017, Theravance Biopharma and Mylan announced the submission of a New Drug Application (NDA) to the FDA for revefenacin (TD-4208), an investigational long-acting muscarinic antagonist (LAMA) as a once-daily, nebulized bronchodilator in development for the treatment of chronic obstructive pulmonary disease (COPD). The NDA is supported by the companies' Phase 3 program for revefenacin, which consisted of two replicate pivotal Phase 3 efficacy studies and a 12-month, open-label, active comparator safety study.
- Theravance Biopharma and Mylan previously reported that in two replicate pivotal Phase 3 efficacy studies, revefenacin demonstrated statistically significant and clinically meaningful improvements as compared to placebo in trough forced expiratory volume in one second (FEV1) and in overall treatment effect on trough FEV1 (OTE FEV1) after 12 weeks of dosing. Both doses of revefenacin had comparable rates of adverse events (AEs) to placebo, low rates of serious adverse events (SAEs), and no clinically meaningful differences in blood parameters or electrocardiogram (ECG) data, across all treatment groups (active and placebo). As previously reported, the most commonly reported adverse events, across both trials and across all treatment groups, were exacerbations, cough, dyspnea and headache.
- Additionally, the companies have previously announced positive results from the 12-month Phase 3 safety study, which did not identify new safety issues. Rates of AEs and SAEs in the study were low and comparable to those seen in the standard of care treatment arm.
Patents:
Submission of marketing authorization application USA : 2017-11-13
Submission of marketing authorization application UE:
Withdrawal of marketing authorization application USA:
Withdrawal of marketing authorization application UE:
US authorization:
UE authorization:
Favourable opinion UE:
Favourable opinion USA:
Orphan status USA:
Orphan status UE:
Pediatric exclusivit _USA:
Pediatric exclusivity UE:
OTC status:
Other news:
Is general: Yes
