While it was expected that the FDA would come up with new label warnings for the use of long-acting beta agonists (LABAs) in asthma drugs, what might have surprised observers is the fact that the agency took it upon itself to single out UK companies GlaxoSmithKline and AstraZeneca in specifically asking them to implement these warnings.
From the companies’ point of view it is unsurprising that they have dragged their heels about the label changes, which were first proposed in February. Advair last year notched up sales of $7.79bn for Glaxo, while Symbicort added $2.29bn to Astra’s coffers (FDA takes tough stance on asthma drugs, February 19, 2010).
But it is not just the big players who have felt the brunt of the new warnings. The FDA’s stance on LABA’s could be behind the hold up in approval of Merck & Co’s Dulera. The asthma drug was filed and accepted by the FDA almost a year a go and a decision had been expected by April or last month at the latest.
The drug, a combination of mometasone and Foradil, which is expected to have sales of $409m by 2016, looks as if it could be mired down in the same discussions around LABAs. However, given the new rules from the FDA even if the drug does get approval it is hard to predict what uptake might be.
The tougher stance on LABAs has also filtered down to some of the partnering decisions made by the bigger pharma companies with drugs in development, which have negatively impacted their smaller licensing partners.
The little guys
In March, Vectura was dealt a blow when Sandoz handed back US rights to VR315, a drug that many had dubbed the son of Advair. It was seen as an indication of the negatively shifting winds in the chances of getting any inhaled drugs currently in late-stage development approved in the US.
Interestingly the group held onto the rights to the drug in Europe, indicating that many believe the path to approval here will not be so onerous.
In a further signal that large pharma groups could be changing their strategy regarding inhaled drugs in America, only a few weeks after handing back US rights to Vectura, Sandoz signed a deal with Oriel Therapeutics, to take advantage of its new drug delivery platform (Novartis seeks new respiratory bride in Oriel, April 19, 2010).
What has not helped the few companies still developing LABAs and steroid combination products including SkyePharma, which also saw its big partner Abbott Laboratories back out of the filing process, is the continuing uncertainty regarding the huge clinical trials for new drugs containing LABA’s that many are expecting the regulator to demand following an advisory committee in March (Nervous months ahead as FDA verdict on LABA asthma drugs awaited, March 15, 2010).
While there were no details about the expectations of the regulator, it is almost certain that large patient trials will be required to demonstrate the safety of products. With this expensive sword of Damocles hanging over the sector it is perhaps not surprising that many big pharma companies are bailing out, leaving their smaller partners to shoulder the expense and risk.
Business as usual
As for the likes of Astra and Glaxo, despite getting their gentle rap on the knuckles from the FDA, little should change, despite the new guidelines stating that asthma drugs containing LABAs should only be used to stabilise patients, who should then be weaned off to other therapies including inhaled steroids or oral products such as Singulair.
Mike Ward, analyst with Ambrian, argued that it would be hard to see doctors switching patients from Advair or Symbicort. “If you have a patient who is happy and has their asthma under control then why are you going to change them onto another therapy,” he said.
“The FDA will be pleased to be seen to have done something in terms of public safety, but is that going to change what is happening or prescribing habits? No,” he added.