• 28 Jun 2025
• Admin
• News Article

Theravance Biopharma announces Viatris receives China NMPA approval for Yupelri inhalation solution to treat COPD

Overview

Theravance Biopharma, Inc. announced that Viatris Inc. (Viatris), has secured regulatory approval from China's National Medical Products Administration (NMPA) for Yupelri (revefenacin) inhalation solution, the first once–daily nebulized long–acting muscarinic antagonist (LAMA) approved for maintenance treatment of chronic obstructive pulmonary disease (COPD) in China.

Both companies’ milestones post approval

• This approval triggers a one-time $7.5 million milestone from Viatris to Theravance Biopharma, which is expected to be received in Q3 2025. 
• Theravance Biopharma is also eligible for further sales-based milestones of up to $37.5 million and tiered royalties of 14% to 20% on net sales in China. 
• Viatris is responsible for all aspects of development and commercialization of Yupelri in China.

Theravance Biopharma Strengthens Financial Position and Advances Ampreloxetine Study

• Theravance Biopharma reports a diversified and improving financial position, supported by:
  - $131 million in cash as of March 31, 2025.
  - $225 million from the recent sale of Trelegy royalties to GSK.
  - 35% share of U.S. Yupelri profits.
  - Up to $150 million in near-term potential milestone payments related to Trelegy from Royalty Pharma
• The announcement coincides with the company nearing completion of enrollment in the open-label portion of CYPRESS, a registrational study evaluating ampreloxetine in symptomatic neurogenic orthostatic hypotension (nOH) associated with multiple system atrophy (MSA).
• Ampreloxetine, a wholly-owned investigational therapy, aims to address a significant unmet need in this rare neurological disorder.

The drug: Ampreloxetine

• Ampreloxetine, an investigational, once-daily, selective norepinephrine reuptake inhibitor in development for the treatment of symptomatic neurogenic orthostatic hypotension (nOH) in patients with multiple system atrophy (MSA). 
• The unique benefits of ampreloxetine treatment reported in MSA patients from Study 0170 included an increase in norepinephrine levels, a favourable impact on blood pressure, clinically meaningful and durable symptom improvement, and no signal for worsening of supine hypertension.
• In the US, the company has been granted an Orphan Drug Designation for ampreloxetine for the treatment of symptomatic nOH in patients with MSA and, if results from the ongoing phase 3 CYPRESS study are supportive, plans to file an NDA for full approval in this indication.

The current trial: Study 0197

• Study 0197 (NCT05696717) is currently enrolling. This is a registrational phase 3, multi-center, randomized withdrawal study to evaluate the efficacy and durability of ampreloxetine in participants with MSA and symptomatic nOH after 20 weeks of treatment; the primary endpoint of the study is change in the Orthostatic Hypotension Symptom Assessment (OHSA) composite score.
• The Study includes four periods:
  - screening, open label (12-week period, participants will receive a single daily 10 mg dose of ampreloxetine), 
  - randomized withdrawal (eight-week period, double-blind, 
  - placebo-controlled, participants will receive a single daily 10 mg dose of placebo or ampreloxetine),
  - and a long-term treatment extension. 
• Secondary outcome measures include change from baseline in Orthostatic Hypotension Daily Activity Scale (OHDAS) item 1 (activities that require standing for a short time) and item 3 (activities that require walking for a short time).

About the company: Theravance Biopharma, Inc.

• Theravance Biopharma, Inc.'s focus is to deliver Medicines that Make a Difference in people's lives. 
• In pursuit of its purpose, Theravance Biopharma leverages decades of expertise, which has led to the development of FDA-approved Yupelri (revefenacin) inhalation solution indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD).