1. Pink Sheet
  2. >>Product Reviews
  3. >>Approvals

FDA Approves GSK’s Anoro Ellipta, The First LABA/LAMA Combination

 
• By Jessica Merrill

FDA approved GSK’s Anoro Ellipta as the first LABA/LAMA combination product in the U.S. for the maintenance treatment of COPD Dec. 18, positioning GSK to launch a second respiratory product months after launching Breo Ellipta.

GlaxoSmithKline PLC will launch Anoro Ellipta (umeclidinium/vilanterol) in the first quarter. The once-daily long-acting muscarinic antagonist (LAMA) and long-acting beta2-adrenergic agonist (LABA) was approved by FDA for the maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease Dec. 18.

The approval marks the first LAMA/LABA combination product to clear FDA and is a back-to-back win for GSK, which is in the midst of launching Breo Ellipta (fluticasone furoate/vilanterol), the...

More from Approvals

Novavax’s COVID-19 Vaccine Label Narrowed After Political Officials Intervened

 
• By Sarah Karlin-Smith

The label that Novavax's COVID-19 vaccine was slated to receive before political officials held up the approval was broader than was granted 16 May.

EU Moment Of Truth For Obe-Cel And 10 Other New Medicines

 
• By Neena Brizmohun

Autolus’s CAR T therapy obe-cel is among the medicines that are this week due for an opinion by the European Medicines Agency on whether they should be marketed in the EU.

Blenrep’s Revival Gains Steam: EMA Decision Imminent As Japan Approves New Regimen

 
• By Neena Brizmohun

The European Medicines Agency is due to decide whether GSK’s previously approved multiple myeloma drug that was withdrawn from the market in 2022 should be approved again for use in combination with BorDex or PomDex. Meanwhile, Japan today became the second major regulator to approve the Blenrep combinations.

New EU Filings

 
• By Neena Brizmohun

Brensocatib, Insmed's investigational treatment for non-cystic fibrosis bronchiectasis, is among the latest products that have been filed for review by the European Medicines Agency for potential EU marketing approval.

More from Product Reviews