Teva's Cinqair OK'd, But Narrower Use Than GSK's Nucala
This article was originally published in Scrip
Teva Pharmaceutical Industries Ltd. gained US approval on March 23 to market Cinqair (reslizumab) as an add-on maintenance treatment for adults 18 years or older with severe asthma with an eosinophilic phenotype.
But the FDA turned the Israeli firm down on use of the drug in the adolescent population – meaning it's going to have a tougher time competing against GlaxoSmithKline PLC's Nucala (mepolizumab), which won the broader use.
There are several similarities between Cinqair and Nucala.
For instance, both drugs are monoclonal antibodies that inhibit interleukin-5 (IL-5), the main promoter of eosinophil growth, activation and survival.
The labels for both products emphasize they are not approved as treatments for other eosinophilic conditions or for the relief of acute bronchospasm or status asthmaticus.
And both of the FDA panels convened to examine the applications for Cinqair and Nucala advised against use of the drugs in adolescents 12-17 years – declaring there was a lack of data in that population for both anti-IL-5 medicines.
But in Nucala's case, the FDA decided to overrule the Pulmonary-Allergy Drugs Advisory Committee when the agency this past November approved the drug – the first anti-IL-5 treatment OK'd in the US for severe asthma – and gave its blessing for use of the product in the younger age group.
Regulators, however, didn't do the same for Cinqair.
Both Cinqair and Nucala are administered every four weeks, but Teva's drug is given as an intravenous infusion over 20-50 minutes, whereas GSK's product is administered subcutaneously.
Teva has not revealed the price of its drug, but spokeswoman Michelle Larkin told Scrip Cinqair's cost would be "similar to other asthma biologics and largely reflective of investments made to research, develop and commercialize a safe and effective biologic treatment."
Nucala was priced last fall at $2,500 per vial.
"It is important to Teva that this product is priced fairly, so patients may be able to access this medication," Larkin said, adding the company would not discuss details about pricing until closer to commercial availability, which is expected in the second quarter.
She said Teva has created a "biologic-specific" sales force to focus on specialists treating the severe asthma patient population and to support staff at the infusion sites where Cinqair will be administered.
Teva's Support Solutions program will provide personalized support, training and education to health care providers and patients who have been prescribed Cinqair, the company said.
Asthma often is characterized by an accumulation of white blood cells, or eosinophils, in lung tissues. In general, eosinophil levels correlate with severity and frequency of exacerbations of asthma.
Patients with eosinophilic inflammation, which makes up only about 3% of the 25 million Americans with asthma, but account for about 50% of the direct health care costs related to the disease, are a very difficult population to treat.
The FDA approved Cinqair based on the data from five placebo-controlled studies, which demonstrated the efficacy and safety profile in a population of 1,028 adult and adolescent asthma patients treated with the drug at the 3mg/kg dosage who were inadequately controlled with inhaled corticosteroid-based therapies.
Three of Teva's studies constituted the Phase III program in patients with asthma and elevated blood eosinophils, the company said.
The trials also demonstrated that treatment with Cinqair was associated with reduction in asthma exacerbations of up to 59%, in addition to significant improvement in lung function, symptoms and asthma-related quality of life, Teva reported.
The most common adverse reaction with an incidence greater than or equal to 2% in patients treated with Cinqair was oropharyngeal pain.
Anaphylaxis was reported at a rate of 0.3% in the placebo-controlled studies, Teva said.
In addition, an imbalance in malignancy was observed in the Phase III trials of 0.6% for Cinqair, versus 0.3% for placebo.
Teva said the observed malignancies were "diverse in nature and were diagnosed within less than six months of exposure to Cinqair."
Teva's shares took a slight hit on March 23 – falling 1.46%, before closing at $54.05, down 73 cents, or 1.33%.