Drugs

Court Backs FDA Active Moiety Interpretation

A DC federal court has agreed with an FDA interpretation that the statutory three-year clinical investigation exclusivities prohibits approval of second-in-time applications for a drug with the same active moiety as the drug with the exclusivity. Attorney Nicole Stakleff (Pepper Hamilton) writes in her firm’s online Client Alert that Otsuka said that FDA improperly approved Alkermes’ Aristada (aripiprazole lauroxil) application before expiration of Otsuka’s three-year clinical investigation exclusivity periods for its Abilify Maintena (aripirprazole) product.

Stakleff says that under FDA’s chemistry-based approach, the active moiety of aripiprazole lauroxil is N-hydroxymethyl aripiprazole, which is the remaining molecule after it is metabolized after administration. Thus, Abilify Maintena’s active moiety is aripiprazole and the active moiety of Aristada is N-hydroxymethyl aripiprazole.

Otsuka contended that FDA was prohibited from approving Aristrada before expiration of Abilify Maintena’s three-year exclusivity periods because, even though both the active ingredients and the active moieties were different, Aristrada’s application was for the same conditions of approval and also treated the condition in a similar way and relied on similar clinical trials. (The indication was for treating schizophrenia using a once-monthly, long-acting injectable formulation of aripiprazole.)

FDA argued that the law’s exclusivity provisions do not bar a second-in-time drug application if the drug with exclusivity and the drug for which approval is being sought have different active moieties. The court agreed, Stakleff writes, and held that the agency’s interpretation of the statute was reasonable and permissible. The court said that while it may be unfair to allow a second-comer to reference and rely on the innovator’s studies for aripiprazole to obtain approval of a long-acting formulation while avoiding the exclusivity awarded to that same innovator following its required work for a long-acting formulation, a different interpretation could result in marketing exclusivity for the original innovator drug in perpetuity.

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