Sweden's Meda has been boosted by the news that regulators in the USA have given the thumbs-up to Dymista, a treatment for seasonal allergic rhinitis.
The approval from the US Food and Drug Administration for Dymista (azelastine and fluticasone) is based on "several studies involving more than 4,000 patients", including one long-term safety study with more than 600 participants. The combo nasal spray formulation is indicated for patients aged 12 and older with SAR and is expected to be launched during the second half of 2012.
Claiming that Dymista has "consistently showed a rapid and more complete symptom relief than standard treatment", Meda quoted Warner Carr of the Allergy & Asthma Associates of Southern California, and principal investigator in the drug's clinical development programme, as saying that “many patients are dissatisfied with currently available treatments”. He added that “at the first onset of seasonal allergies, Dymista has the potential to help reduce the number of allergy medications patients may need to take and offers greater efficacy than traditional first-line agents". This in turn can lead to "greater compliance and more efficient use of healthcare system resources for this common condition”, Dr Carr concluded.
Meda chief executive Anders Lonner said the approval strengthens the firm's allergy franchise and "gives opportunities for the company to grow and establish collaborations in the field".
…but issues warning over Astepro promotion
The Solna-headquartered company recently received approval for another allergic rhinitis product, Astepro (azelastine), ie a component of Dymista, on both sides of the Atlantic, but certain promotional materials have fallen foul of the FDA.
The agency has posted on its website a letter sent to Meda over a telephone script for Astepro which it describes as "false or misleading because it presents efficacy claims…but fails to include any risks associated with its use". In addition, the script "overstates the efficacy of Astepro…and fails to make adequate provision for dissemination of the FDA-approved labelling".
The FDA's Office of Prescription Drug Promotion has requested that Meda "immediately cease the dissemination of violative promotional materials" and demanded a written response on or before May 10.