Fri, Oct. 2, 5:37 PM
Thu, Oct. 1, 5:35 PM
Thu, Sep. 24, 7:52 AM
- GlaxoSmithKline (NYSE:GSK) and development partner Theravance (NASDAQ:THRX) intend to file a supplemental New Drug Application in Japan (sJNDA) in Q1 2016 seeking clearance for Relvar Ellipta (fluticasone furoate/vilanterol) for the treatment of chronic obstructive pulmonary disease (COPD).
- In September 2013, Relvar Ellipta was approved in Japan for the treatment of asthma in patients at least 15 years old. It is marketed as Breo Ellipta in certain other territories, including the U.S.
Wed, Sep. 9, 12:44 PM
Tue, Sep. 8, 3:30 PM
- A large scale clinical trial, called SUMMIT, involving 16,485 subjects across 43 countries assessing the impact of GlaxoSmithKline (GSK +2%) and Theravance's (NASDAQ:THRX) Relvar/Breo Ellipta (fluticasone/vilanterol dry powder for inhalation) on cardiovascular disease (CVD) in patients with COPD (chronic obstructive pulmonary disease) with either a history or increased risk of CVD failed to achieve its primary endpoint of a statistically significant reduction in the risk of dying compared to placebo (p=0.137) despite an observed reduction of 12.2%.
- A secondary endpoint of reducing the risk of experiencing a CV event while on treatment also failed to achieve statistical significance (p=0.475) despite an observed reduction of 7.4% versus placebo.
- Treatment with Relvar did show a statistically significant reduction in reducing the rate of lung function decline compared to placebo (p=0.019), but statistical significant cannot be inferred because the study failed to achieve its primary endpoint.
- SUMMIT was the first study of its kind with the aim of better understanding the effect of respiratory treatments on COPD patients with a risk of CVD. The company intends to present the data at future medical conferences and for publication.
- The FDA approved the product for COPD in May 2013.
Wed, Jul. 29, 5:01 PM
Wed, Jul. 29, 4:07 PM
Tue, Jul. 28, 10:08 AM
- The European Medicines Agency validates Teva Pharmaceutical Industries' (TEVA -1.6%) Marketing Authorization Application (MAA) for reslizumab for the treatment of inadequately controlled asthma in adult patients with elevated blood eosinophils despite an inhaled corticosteroid-based regimen. A final decision by the European Commission is anticipated in H2 2016.
- Reslizumab is an investigational humanized monoclonal antibody that binds to interleukin-5 (IL-5), a cytokine that plays a key role in the activation and growth of eosinophils, a type of white blood cell that is elevated in the lungs and blood of many asthmatics. High levels of eosinophils correlate with disease severity so binding to IL-5 inhibits its ability to stoke eosinophil levels.
- Teva's Biologics License Application (BLA) is currently under review by the FDA. A decision is expected in March 2016.
- Asthma-related tickers: (SNY -0.1%)(GSK -0.4%)(AZN -0.7%)(OTCQX:RHHBY)(AMGN +2.2%)(MRK -1.1%)(NVS +0.7%)(THRX +1.5%)
Tue, May 26, 9:21 AM
- The FDA approves privately-held Boehringer Ingelheim's once-daily Stiolto Respimat (tiotropium bromide and olodaterol) Inhalation Spray for the maintenance treatment of chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. It is not cleared for the treatment of asthma or acute deterioration of COPD.
- Tiotropium, a long-acting anticholinergic, is the active ingredient in Spiriva, the most prescribed COPD maintenance treatment worldwide. Olodaterol, a long-acting beta2-agonist that complements the efficacy of Spiriva, has a fast onset of action that improves airflow in five minutes after dosing.
- COPD-related tickers: (NASDAQ:TBPH) (NYSE:GSK) (NASDAQ:THRX) (NYSE:AZN) (NYSE:NVS) (NASDAQ:REGN) (NYSE:SNY) (NYSE:TEVA) (OTCQX:RHHBY) (NASDAQ:AQXP)
Wed, May 6, 5:10 PM
Wed, May 6, 4:51 PM
Thu, Apr. 30, 4:46 PM
- As expected, the FDA approves Breo Ellipta (fluticasone furoate and vilanterol powder) for the once-daily treatment of asthma in adult patients at least 18 years old. It is not approved for the treatment of acute bronchospasm.
- Breo Ellipta, co-developed by Theravance (NASDAQ:THRX) and GlaxoSmithKline (NYSE:GSK) was previously approved for the treatment of chronic obstructive pulmonary disease.
- Previously: PDUFA date approaches for expanded use of Breo Ellipta inhaler (April 28)
Tue, Apr. 28, 12:19 PM
- April 30 is the PDUFA date for the FDA's decision on the approval of the use of the Breo Ellipta (fluticasone furoate and vilanterol inhalation powder) inhaler in adult patients with asthma. The Ad Comm vote last month was 18 - 2 in favor of the new indication. Breo Ellipta is currently cleared for the treatment of chronic obstructive pulmonary disease.
- Breo Ellipta was co-developed by Theravance (THRX +3.3%) and GlaxoSmithKline (GSK +0.2%).
Mon, Mar. 23, 4:26 PM
- According to Thomson Reuters' 2015 Drugs to Watch report, as many as 11 blockbuster drugs (peak sales of at least $1B within five years) are expected to clear the regulatory process this year. This is a significant jump from 2014's tally of three (Gilead's (NASDAQ:GILD) Sovaldi and Zydelig; Glaxo (NYSE:GSK) and Theravance's (NASDAQ:THRX) Anoro Ellipta). In reverse order (forecasted 2019 consensus sales in parentheses):
- 11. Novartis' (NYSE:NVS) Cosentyx (secukinumab) for psoriasis and psoriatic arthritis ($1.08B); 10. Sanofi's (NYSE:SNY) Toujeo (insulin glargine) for diabetes ($1.26B); 9. Otsuka Pharmaceutical (OTCPK:OTSKY) and Lundbeck's (OTCPK:HLUYY) Brexpiprazole for schizophrenia and depression ($1.35B); 8. Merck's (NYSE:MRK) Gardisil 9 HPV vaccine ($1.64B); 7. Amgen's (NASDAQ:AMGN) evolocumab for hypercholesterolemia/hyperlipidemia ($1.86B); 6. AbbVie's (NYSE:ABBV) Veikira Pak for hepatitis C (cleared 12/19/14) ($2.5B); 5. Vertex Pharmaceuticals' (NASDAQ:VRTX) lumacaftor plus ivacaftor for cystic fibrosis ($2.74B); 4. Pfizer's (NYSE:PFE) Ibrance (palbociclib) for breast cancer ($2.76B); 3. Novartis' LCZ696 for chronic heart failure ($3.73B); 2. Regeneron Pharmaceuticals' (NASDAQ:REGN) Praluent (alirocumab) for hypercholesterolemia ($4.41B) and 1. Bristol-Myers Squibb's (NYSE:BMY) Opdivo (nivolumab) for melanoma ($5.68B).
Fri, Mar. 20, 9:23 AM
Thu, Mar. 19, 7:24 PM
- Theravance (NASDAQ:THRX) has fallen to $16.11 in AH trading after the FDA advisory committee backed the use of GlaxoSmithKline's Breo Ellipta inhaler for treating asthma in adults, but not in adolescents.
- Theravance, which co-developed Breo Ellipta with Glaxo and receives royalties on its sale, was halted today in advance of the decision. CEO Michael Aguiar, discussing the decisions in a PR: "We remain committed to the ongoing review process and will be fully cooperating with the FDA to ensure it has all it needs to consider the sNDA for Breo Ellipta in asthma. We look forward to the final outcome expected in April."
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