FDA approves Eisai thyroid drug, fast-tracks Novartis heart pill
pharmafile | February 16, 2015 | News story | Sales and Marketing | Eisai, FDA, LCZ696, Lenvima, Novartis, heart, lenvatinib, thyroid
The FDA has approved Eisai’s thyroid cancer drug Lenvima and also granted Novartis heart pill LCZ696 a priority review.
Lenvima (lenvatinib) has been approved in the US to treat the most common type of thyroid cancer – differentiated thyroid cancer (DTC) – and is for patients whose disease has progressed despite receiving radioactive iodine therapy.
DTC is a cancerous growth of the thyroid gland which is located in the neck and helps regulate the body’s metabolism. Lenvima is a kinase inhibitor, which works by blocking certain proteins from helping cancer cells grow and divide.
“The development of new therapies to assist patients with refractory disease is of high importance to the FDA,” says Richard Pazdur, who is the director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research.
“Today’s approval gives patients and healthcare professionals a new therapy to help slow the progression of DTC.”
Lenvima was evaluated under the FDA’s priority review programme, and the drug also received orphan product designation because it is intended to treat a rare disease.
The firm is now trialling the drug for other tumour types, and Lenvima is undergoing regulatory review worldwide and the EU (where it was also granted accelerated assessment).
Speedy FDA review for Novartis
Meanwhile there’s good news for Novartis too as the FDA has granted priority review designation to LCZ696, an investigational medicine for the treatment of heart failure with reduced ejection fraction (HFrEF).
For LCZ696 this means a welcome reduction in the total review time from 12 to 8 months, meaning the FDA could make a decision on approval as early as in August this year.
David Epstein who is the division head at Novartis Pharmaceuticals, says: “The FDA’s decision reflects the significant need to extend and improve life for HFrEF patients and Novartis is working to ensure LCZ696 can become available in the US as soon as possible.”
In the EU the Committee for Medicinal Products for Human Use (CHMP) has also granted accelerated assessment for the heart pill.
Nearly six million people that live with heart failure in the US alone. The twice a day medicine is said to work by reducing the strain on failing hearts, and acts to enhance the protective neurohormonal systems of the heart (NP system) while simultaneously suppressing the harmful system (the RAAS).
Brett Wells
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