Shire plc SHPG provided an update on its plans to respond to a complete response letter (CRL) served by the FDA for the company’s new drug application (NDA) for lifitegrast. The company is looking to get lifitegrast approved for the treatment of the signs and symptoms of dry eye disease in adults.
We remind investors that late last week the company had received a CRL for its NDA for lifitegrast from the FDA. The agency asked Shire to conduct an additional study on the candidate. Additionally, the FDA demanded further information from the company related to the quality of the candidate.
The company stated that it has already completed a phase III study (OPUS-3) evaluating the efficacy and safety of lifitegrast, with top-line data expected by year end. If data from the study is positive, it will form the basis of the company’s response to the CRL. Shire intends to resubmit its NDA for liftegrast in the first quarter of 2016. The company said that it remains on track for the planned launch of lifitegrast in 2016 (if approved).
Our Take
The FDA’s denial to approve Shire’s NDA for liftegrast is a definite setback for the company. Shire highly depends on data from the OPUS-3 study for the approval of liftegrast, going forward.
We expect investor focus to remain on pipeline and regulatory updates on liftegrast.
Meanwhile, we remind note that Shire is well-known for its attention deficit hyperactivity disorder ADHD portfolio which includes drugs like Intuniv, Vyvanse and Adderall XR. Other drugs approved for ADHD include Eli Lilly and Company’s LLY Strattera, Johnson & Johnson’s (JNJ) Concerta and Novartis’ NVS Ritalin.
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