Business Context and Reporting Period
Company: GlaxoSmithKline plc (GSK)
Filing Type: Form 6-K (Report of Foreign Issuer)
Reporting Period: October 27, 2015
Subject: Announcement of results from the AUSTRI (SAS115359) safety study regarding the product Advair Diskus (salmeterol/fluticasone propionate).
Key Financial Metrics
The filing text does not provide a clear value for revenue, profit, cash flow, margins, debt, or liquidity. This document is a regulatory announcement regarding clinical trial results and does not contain financial statements or performance metrics.
Material Changes and Clinical Results
The primary material event is the completion of the AUSTRI study, a post-marketing requirement by the US FDA. Key findings include:
- Study Scope: 26-week, global, multicentre study involving 11,751 patients across 33 countries (adolescents and adults).
- Primary Endpoint: The study assessed the risk of serious asthma-related events (deaths, intubations, or hospitalisations).
- Outcome: Advair Diskus demonstrated non-inferiority compared to fluticasone propionate (FP) monotherapy. The Hazard Ratio was 1.029 (95% CI 0.638, 1.662; p=0.003).
- Event Counts: 67 total serious asthma-related events occurred (34 on Advair Diskus, 33 on FP monotherapy). No asthma-related deaths were recorded in either arm.
- Intubations: Two asthma-related intubations occurred, both in the FP monotherapy arm.
Outlook, Risks, and Management Commentary
Regulatory Next Steps: GSK will share these findings with the FDA to discuss next steps. This is the first of four large-scale safety studies (undertaken by GSK and three other manufacturers) to report results.
Pipeline Update: GSK is conducting a second LABA safety study, VESTRI, in children aged 4-11. The study is on track to report results at the end of Q1 2016.
Risks and Safety Warnings: The filing reiterates significant safety warnings associated with Long-acting beta2-adrenergic agonists (LABAs):
- Asthma-Related Death: LABAs increase the risk of asthma-related death. Physicians should only prescribe Advair Diskus for patients not adequately controlled on inhaled corticosteroids alone.
- Contraindications: Not indicated for relief of acute bronchospasm or status asthmaticus.
- Adverse Reactions: Common reactions include upper respiratory tract infection, pharyngitis, and oral candidiasis. Long-term use may affect bone mineral density and growth velocity in pediatric patients.
- Drug Interactions: Strong CYP3A4 inhibitors are not recommended due to increased systemic corticosteroid effects.
Investor Verification Checklist
- Confirm the FDA's official response and any subsequent regulatory actions following the submission of AUSTRI results.
- Monitor the timeline and results of the VESTRI study (pediatric population) expected in Q1 2016.
- Review the impact of these safety confirmations on the commercial performance of Advair/Seretide, particularly regarding patent cliffs and generic competition.
- Verify if the non-inferiority results alter prescribing guidelines or market share relative to competitor LABA/ICS products.