Alembic Pharma reports first prescription sale of Pivya

Alembic Pharma reports first prescription sale of Pivya

Alembic Therapeutics LLC announced the U.S. launch of Pivya® (pivmecillinam) tablets, 185mg, an oral antibiotic for uncomplicated urinary tract infections (uUTI) in women aged 18 and older, on February 18, 2026. The drug, previously approved by the FDA in April 2024, was acquired by Alembic through its purchase of UTILITY Therapeutics in July 2025. Pivya, a beta-lactam antibiotic with a novel mechanism targeting gram-negative bacteria, had been used for over 40 years in Europe and Canada with limited resistance development.

The launch marks Alembic's first commercial product in the U.S. women's healthcare segment, aligning with its strategy to leverage global research and regulatory expertise. Clinical trials demonstrated Pivya's efficacy against uUTI-causing pathogens like Escherichia coli and Proteus mirabilis, with composite response rates exceeding 60% in placebo-controlled trials. However, the drug carries warnings for hypersensitivity reactions, carnitine depletion risks, and potential interference with newborn screening tests.

Alembic's CEO, Craig Salmon, emphasized that Pivya's introduction strengthens the company's portfolio and long-term value proposition by addressing unmet needs in antimicrobial therapy. Dr. Keith Kaye, an infectious disease expert, noted Pivya's potential as a first-line treatment, citing its alignment with Infectious Disease Society of America guidelines. The product is packaged in child-resistant blisters and distributed under U.S. regulatory standards.

This launch reflects Alembic's focus on specialty markets and access to innovative therapies, following its acquisition of UTILITY's FDA-approved asset. Financial implications for the company will depend on market adoption and competition within the uUTI treatment landscape.