New COPD and asthma treatments jostle for market space
pharmafile | October 6, 2010 | Feature | Research and Development, Sales and Marketing | COPD, Daxas, Onbrez Breezhaler, Revolair, asthma
Competition in the field of COPD and asthma is hotting up, with new data for several key treatments recently unveiled.
Chronic Obstructive Pulmonary Disorder is one of the world’s biggest killers, but remains relatively unknown and little understood by the general public.
COPD encapsulates two diseases, chronic bronchitis and emphysema, and is usually caused by smoking. An estimated 210 million people worldwide suffer from the condition, and it is projected to be the third leading cause of death worldwide by 2020.
GSK’s Seretide (Advair in the US) is the biggest selling drug in the market, earning just under $8 billion last year, while Boehringer Ingelheim and Pfizer’s Spiriva earned $3.35 billion.
Advair is approaching the end of its US patent life, but the complicated nature of its formulation and manufacturing means it is unlikely to face the usual intense generic competition once it goes off patent.
Nevertheless, new drugs are needed to help with progress in the treatment of COPD, which remains impossible to cure or even to halt in its progression.
The European Respiratory Society congress was held in Barcelona in September, with key data presented by Nycomed, GSK and Novartis on the next generation of asthma and COPD drugs.
Daxas
Nycomed’s Daxas (roflumilast) has perhaps the most innovative approach to treating COPD, but its future success still hangs in the balance.
The drug is the first in a new class of anti-inflammatory treatments for severe COPD, and is moreover a once-daily pill, making it very patient-friendly.
The drug is licensed for use with bronchodilator treatments, which means it will go head-to-head with treatments containing corticosteroids.
The new data on Daxas showed patients suffered fewer exacerbations, and also showed that the greatest benefit of Daxas was seen in patients with a history of frequent exacerbations (two or more per year).
The drug is a selective, long-acting inhibitor of the PDE-4 enzyme and targets cells and mediators in the body believed to be important in COPD and other inflammatory diseases.
The phase III drug is approved and co-promoted in Europe by Nycomed and Merck Sharpe & Dohme, and was recently launched in Germany and the UK.
Daxas will be launched in seven additional European countries by the end of this year, and is scheduled to be launched in other markets during 2011.
But the drug’s approval in the US still looks uncertain. Daxas was rejected in April this year by an FDA committee, which said Forest (Nycomed’s US marketing partner) had not provided substantial evidence to support its filing. Forest announced in early September that following further discussions with the FDA, it expected the regulator to pass its ruling in the first quarter of 2011.
Relovair
GSK is looking to produce a successor to Seretide/Advair in the shape of Relovair.
The company has conducted additional phase II trials on its asthma/COPD drug to answer a number of safety and efficacy questions.
Relovair combines a new long-acting beta agonist vilanterol trifenatate (VI), and GSK’s existing corticosteroid, fluticasone furoate (FF).
The findings included results showing Relovair did not adversely affect heart function, while other studies showed VI improved lung function in COPD patients. This is the first time that GlaxoSmithKline and its partner Theravance have revealed detailed clinical trial data for the new combination drug, although encouraging results have previously been presented for the medicine’s two separate components.
Phase III trials of once-daily Relovair in COPD and asthma, commenced in October 2009 and March 2010 respectively. Analysts at Citigroup said Relovair showed an improvement over Seretide in helping patients increase their lung capacity, using the FEV1 measure. Data showed Relovair produced an improvement in FEV1 compared to placebo of 183 millilitres after 29 days. Seretide by comparison, produced an average 165ml improvement after six months.
The phase III programmes are assessing the potential benefit of the combination FF/VI versus the component products and existing treatments for asthma and COPD in over 11,000 patients.
Onbrez
Data from Novartis’ INSIST study shows its once-daily Onbrez Breezhaler (indacterol) is significantly better at improving lung function and reducing breathlessness than twice-daily Serevent (salmeterol).
Onbrez Breezhaler is already approved in Europe and other markets, but the FDA has requested additional data and Novartis expects to file for approval in the US by the end of the year.
The study involved over 1,000 patients and showed that Onbrez Breezhaler provided superior 24-hour bronchodilation to salmeterol at the end of 12 weeks’ treatment.
Dr Stephanie Korn, the study’s principal investigator, added: “Patients with COPD require treatment that combines a sustained improvement in lung function with better clinical outcomes. The results of INSIST confirm that indacaterol is potentially an attractive maintenance treatment option for these patients.”
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