GSK/Theravance lung drug bags CHMP approval
pharmafile | February 21, 2014 | News story | Sales and Marketing | CHMP, COPD, GSK, Theravance, anoro
The CHMP has given its backing to GlaxoSmithKline and partner Theravance’s new chronic obstructive pulmonary disease medicine Anoro.
The treatment brings together UMEC, a long-acting muscarinic antagonist, and VI, a long-acting beta agonist, as a single inhaler.
Patrick Vallance, GSK’s president of Pharmaceuticals R&D, said: “Today’s positive opinion is a step towards us making this important new medicine available. We are looking forward to the final decision of the European Commission in the near future.”
Chief executive of Theravance, Rick Winningham, added: “This is an important milestone and reflects the ongoing efforts of the collaboration between Theravance and GSK to research and develop new respiratory medicines that meet patient’s needs.”
But GSK will not be entering this marketplace alone and its rivals include Merck and Nycomed’s once-daily pill Daxas (roflumilast), and Boehringer Ingelheim/Pfizer’s Spiriva (tiotropium bromide inhalation powder).
It will become a partial successor to GSK’s blockbuster respiratory treatment Seretide/Advair (salmeterol xinafoate/fluticasone propionate). This drug made more than $8 billion in sales last year.
GSK’s new treatment at its peak is expected to generate fewer sales, with estimates from analysts seeing just $2 billion a year by 2018. GSK said last year it expected sales of around $5 billion at their peak.
Although Seretide’s patent has already lapsed in a number of markets, those companies which have tried to create a generic have failed, given its complicated formulation.
Sales of the drug have dropped slightly over the past three years, but it should continue to deliver strong blockbuster income in the years ahead – meaning Anoro will be adding to any lost revenue, rather than trying to replace it completely.
The CHMP’s decision must now be ratified by the European Commission, a process that usually takes around three months. In a different strength formulation the drug gained FDA approval in December last year.
The World Health Organization estimates that more than 21 million people are currently living with COPD, mainly as a result of long-term smokers.
GSK and Theravance also develop the COPD/respiratory drug which previously known as Relovair, but has now been renamed as Breo in the US and Relvar in Europe.
This treatment had a mixed bag of results after it initially failed to best Advair, and also faced scrutiny over the risk of pneumonia death in patients taking the product.
The FDA approved Breo in May last year, however, after GSK convinced the regulator the drug was safe and efficacious.
Breo is a combination of the inhaled corticosteroid fluticasone furoate, and the long-acting beta2 agonist (LABA) vilanterol.
Ben Adams
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