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FDA Approves Orlynvah for Treatment of Uncomplicated UTIs in Women with Limited Options

• The FDA has approved Orlynvah (sulopenem etzadroxil and probenecid), an oral antibiotic, for uncomplicated urinary tract infections (UTIs) in adult women with limited treatment options. • Orlynvah is intended for use when other oral antibacterial treatments are not suitable or unavailable, addressing a critical unmet need for women facing recurrent UTIs. • Clinical trials demonstrated the drug's efficacy in treating UTIs caused by susceptible bacteria, offering a new option for patients who have run out of alternatives. • Ottimo Pharma, led by former Seagen CEO David Epstein, is developing an experimental antibody targeting PD-1 and VEGF for cancer treatment.

The U.S. Food and Drug Administration (FDA) has granted approval to Iterum Therapeutics' Orlynvah (sulopenem etzadroxil and probenecid), an oral antibiotic, for the treatment of uncomplicated urinary tract infections (UTIs) in adult women. This approval addresses a significant gap in treatment options for women who have limited or no alternative oral antibacterial therapies available.

Addressing Unmet Needs in UTI Treatment

UTIs are common bacterial infections, particularly among women. Orlynvah is specifically indicated for uncomplicated UTIs caused by susceptible bacteria in women who have exhausted other oral treatment options. This approval provides a new tool for healthcare providers facing the challenge of recurrent or resistant UTIs.
The drug is expected to be available around mid-2025.

Ottimo Pharma's Immuno-Oncology Approach

In other news, Ottimo Pharma, a new company led by former Seagen CEO David Epstein, is focusing on developing a novel cancer therapy. The company's experimental antibody targets both PD-1 and VEGF, two proteins involved in immune regulation and angiogenesis, respectively. This dual-targeting approach represents a promising strategy in immuno-oncology.
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[1]
FDA Approves New UTI Drug For Women Who Have Run Out Of Options - KFF Health News
kffhealthnews.org · Oct 28, 2024

FDA approves Orlynvah, a new UTI drug for adult women with limited treatment options, set to be available by mid-2025. A...

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