Drugs

Support, Questions on Antibiotic Pathway Guidance

Pew Charitable Trusts says that an FDA proposed limited population antibacterial drug pathway gives the agency a mechanism to review and approve new antibiotics specifically for use in patients with unmet medical needs. In a comment to an agency docket on the pathway, Pew says the pathway allows approval of antibiotics in limited populations of patients with unmet medical need by considering the benefits and risks for patients with few or no treatment options. “Pew supports the policies and processes in the draft document and offers recommendations on proper use, labeling, and stewardship,” the comment letter says.

The Infectious Diseases Society of America (IDSA)says it appreciates the agency recognizing the gravity of antimicrobial resistance and the fragility of the antibiotic pipeline. “Very few large companies remain engaged in antibiotic discovery and development,” it says, “while patient needs for new antibiotics continue to grow. Without a robust and renewable antibiotic pipeline, increasing numbers of once treatable infections will become deadly, and modern medical advances like chemotherapy, transplants, and other complex surgeries could become too dangerous to perform, undoing decades of progress against disease.” IDSA says the limited population pathway is essential to strengthening the antibiotic pipeline because many of the deadliest infections with the fewest treatment options occur at the moment in relatively smaller numbers of people that makes traditional, large-scale clinical trials infeasible. Also, new antibiotics with activity against the most difficult to treat pathogens should be used only in the patients who truly need them to protect their utility against the development of resistance. “The limited population pathway addresses both of these challenges and, if utilized, can help bring to market some of the most urgently needed new antibiotics and promote their appropriate use,” the society says.

Merck says it is one of a few large drug companies pursuing research and development on new products to prevent and treat bacterial infections. “We recognize that the limited population pathway for antibacterial and antifungal drugs may help deliver critically-needed treatments to patients with few or no options,” its comment letter says. It provides its comments on considerations for approval of drugs under the pathway, carton labeling and immediate container label, highlights of prescribing information, and promotional materials.

GlaxoSmithKline offers specific line-by-line comments on the draft document.

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FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

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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