Drugs

FDA Rejects Xspray Pharma's Nilopki Application

FDA has issued Xspray Pharma a complete response letter for the company's NDA for Nilopki, an improved formulation of nilotinib designed to compete with Novartis' chronic myeloid leukemia (CML) therapy Tasigna. FDA told the company that it is unable to approve the application in its current form, citing concerns related to dosing comparability, manufacturing data and outstanding issues involving a third-party manufacturing facility.

According to the company, FDA identified three primary deficiencies in the application. First, reviewers said the proposed labeling and dosing regimen must establish a single corresponding Nilopki dose level for each Tasigna dose level, beginning with a dose that produces drug exposure comparable to Tasigna's 200-milligram strength.

Second, FDA requested additional information demonstrating commercial-scale manufacturing capability for batches of nilotinib produced using Xspray's amorphous solid dispersion technology.

Third, the agency indicated that Xspray's contract manufacturing partner must adequately address observations identified during an FDA inspection. The agency also noted that a pre-approval inspection related to Xspray's manufacturing operations may still be required before approval can be granted.

Xspreay says Nilopki was developed as an improved version of Tasigna for patients with chronic myeloid leukemia. Xspray has contended that the product addresses one of the most burdensome aspects of current nilotinib therapy: strict fasting requirements. Patients taking Tasigna must avoid food before and after dosing, resulting in up to six hours of fasting daily, it says.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome