FDA Advisors Recommend Teva’s Asthma Drug, But Not for Adolescents

With such a strong unmet need in severe asthma patients and convincing evidence of improvement in this population, Teva Pharmaceuticals’ candidate reslizumab warrants approval, FDA advisors said Wednesday.

The Pulmonary-Allergy Drugs Advisory Committee voted 11 to 3 in favor of recommending the injectable monoclonal antibody. However, they unanimously balked at supporting its approval in youth ages 12 to 17 since just 19 patients in that age group had been studied.

“Clinicians will probably use this very cautiously,” said Dennis Ownby, committee chair and Georgia Regents University pediatrics professor, who “reluctantly” voted yes.

Reslizumab (Cinqair), an anti-IL-5 monoclonal antibody which targets a subgroup of patients with asthma with an eosinophilic phenotype, was studied in 1,311 patients with five trials pivotal to the submission. The results showed improvements in lung function in late phases, as well as in exacerbation rates and asthma-control responses, according to FDA briefing documents released Monday (DID, Dec. 8).

The drug’s effects were lesser known and trended negative in some cases in specific populations with smaller sample sizes such as African Americans and adolescents.

The committee suggested the mixed benefit could be addressed with product labeling and post-marketing patient pharmacovigilance, and panelists supported reslizumab’s efficacy profile for the asthma treatment, with just one advisor disagreeing.

Threatening to trip up Teva’s relatively positive efficacy findings, the FDA flagged concerns about anaphylaxis — seen in three patients — and muscle toxicity.

Others felt the risk of reaction was well-characterized and no different from other biologics approved on the market.

Overall, panelists voted 11 to 3 in favor of the asthma candidate’s safety profile.

The support came with several caveats.

Advisors recommended robust post-approval surveillance for all of the flagged risks and more exploration of creatinine increases. Other precautions such as “fairly strong” label warnings and a requirement that IV infusion take place in medical settings — not at home — in case of allergic reaction were suggested.

They also echoed the FDA’s concerns about using a smaller dose of .3 milligrams — which saw similar benefits as the larger dose but was abandoned. — Victoria Pelham


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