Teva’s Cinqair To Join Nucala For Severe Asthma After FDA Approval
This article was originally published in The Pink Sheet Daily
Executive Summary
FDA approved the interleukin-5 antagonist reslizumab March 23 for the treatment of severe asthma in patients 18 and older who have an eosinophilic phenotype.
Teva Pharmaceutical Industries Ltd.’s Cinqair (reslizumab) will join GlaxoSmithKline PLC’s Nucala (mepolizumab) as the second biologic on the market for eosinophilic severe asthma following the drug’s FDA approval March 23. The company expects to launch Cinqair in the second quarter.
The two interleukin-5 antagonists carry similar indications, but have important differences. Both are approved as add-on maintenance treatment in patients with an eosinophilic phenotype. However, GSK’s Nucala appears to have an early edge because it is approved in patients 12 and older, while Cinqair is approved only in patients 18 and older.
Teva said it will not disclose details on pricing for Cinqair until closer to launch, but the company said it “will be similar to other asthma biologics.”
Cinqair, like Nucala, works by stopping IL-5 from binding to its receptor on eosinophils, white blood cells that contribute to the development of asthma. The drugs are targeted to just a small subset of patients with asthma, as only about 5% to 10% of the 242 million people living with asthma worldwide are severe asthmatics. GSK previously said it believed Nucala would be relevant to about 300,000 to 400,000 patients.
As with Nucala, FDA has avoided specific definition of the eosinophilic phenotype while approving Cinqair (Also see "Birth Of A Biomarker? FDA Doesn't Define Eosinophilic Asthma, Defers To Docs On Nucala" - Pink Sheet, 21 Mar, 2016.). The Cinqair indication specifies use in severe asthma patients with an eosinophilic phenotype, but offers no instructions other than the mention of the threshold used in the clinical studies (400/mcL).
The companies hope the targeted patient population will help to justify the cost of the more expensive biologics to payers, especially since the medicines will be used on top of therapy.
GSK priced Nucala at a wholesale acquisition cost of $2,500 per vial, which is administered every four weeks on top of high-dose inhaled corticosteroids and at least one additional asthma control medicine.
Teva said it will not disclose details on pricing for Cinqair until closer to launch, but the company said, “The price of Cinqair will be similar to other asthma biologics.”
“It is important to Teva that this product is priced fairly, so patients may be able to access this medication,” the company added.
There are some safety and convenience differences between the two biologics. Nucala is dosed once monthly via subcutaneous injection, while Cinqair 3mg/kg is administered via a 20- to 50-minute intravenous infusion, also once monthly. Teva is in the process of developing a subcutaneous version of reslizumab.
In addition, Teva’s drug needs to be administered by a health care professional prepared to manage anaphylaxis, according to labeling, while labeling for Nucala does not include the same requirement for managing anaphylaxis. Nonetheless, cases of anaphylaxis in reslizumab clinical testing were rare, a rate of 0.3% in the placebo-controlled trials supporting the approval.
Another risk of Cinqair, also rare (0.6% of patients in clinical studies), is malignancy. Nucala does not carry that warning, but does have a warning of herpes zoster infections.
GSK also has a small lead in the market; Nucala launched late in 2015 on the heels of a Nov. 4 FDA approval (Also see "GSK To Launch Mepolizumab For Severe Asthma By Year-End" - Pink Sheet, 4 Nov, 2015.).
FDA Heeds Ad Comm On Adolescents
The indication for Cinqair follows the recommendations of FDA’s Pulmonary-Allergy Drugs Advisory Committee, which in December voted 11-3 in favor of the efficacy and safety data supporting the approval of reslizumab in patients 18 and older, but unanimously agreed there was not substantial evidence of a clinically meaningful benefit in patients ages 12 to 17 (Also see "Teva's Reslizumab Gets Panel Nod For Adult Asthma, Unanimous 'No' For Adolescents" - Pink Sheet, 9 Dec, 2015.).
The pivotal trial efficacy database consisted of only 25 patients in the 12-17 age group, with unfavorable or neutral trends on lung function and exacerbations.
The approval was based on data from five placebo-controlled studies involving 1,028 patients treated with Cinqair whose asthma was inadequately controlled with inhaled corticosteroid-based therapies. Three of the studies were Phase III trials in patients with asthma and elevated blood eosinophils. The data demonstrated that treatment with Cinqair was associated with reduction in asthma exacerbation of up to 50% as well as improvement in lung function.
Labeling says patients receiving Cinqair 3 mg/kg administered every four weeks had significant reductions in the rate of all asthma exacerbations compared to placebo and that exacerbations requiring the use of systemic corticosteroids as well as exacerbations resulting in hospitalization or emergency room visits were each reduced.
The labeling for Nucala has similar language on reductions in exacerbations, as well as reduced hospitalizations and emergency room visits