Ongoing | Infectious Disease Accelerated Approvals (excluding vaccines)
This listing includes accelerated approvals (AAs) for infectious disease indications that have postmarketing requirement(s) for ongoing clinical trial(s) to verify clinical benefit.
Please refer to Drugs@FDA for the latest approvals and prescribing information for specific products. See Postmarket Requirements and Commitments for the status of specific requirements.
Visit Accelerated Approvals for listings of ongoing, verified clinical benefit, and withdrawn infectious diseases and non-malignant hematological, neurological, and other disorder indications accelerated approvals.
Indications may remain on this page until FDA updates product labeling or publishes a Federal Register notice regarding a change in status.
Ongoing 1 Infectious Diseases Accelerated Approvals
Total approval time was adjusted based on management decision. This is a legacy practice and is no longer exercised.
| Drug Name | Accelerated Approval Indication | Accelerated Approval Date | AA PMR | Original Projected Completion Date 2 |
|---|---|---|---|---|
| Lampit (nifurtimox) | For the treatment of chagas disease in pediatric patients birth to less than 18 years of age and weighing at least 2.5 kg | 8/6/2020 | PMR 3868-1: Complete the CHICO SECURE part of Study 16027 to determine the seroconversion rate in subjects treated with nifurtimox at the 4-year timepoint. Obtain antibody titers by serial dilution for all available serum samples measured by the F29-ELISA, Recombinant-ELISA and Lysate-ELISA in addition to IHA. | 2/28/2022 |
| Sirturo (bedaquiline) | For the treatment of pulmonary multi-drug resistant tuberculosis as part of combination therapy, in adult and pediatric patients (12 to less than 18 years of age and weighing at least 30 kg) to include patients ≥ 5 to <12 years of age and weighing at least 15 kg | 5/27/2020 | PMR 1988-1: Conduct a confirmatory randomized double blind placebo controlled multicenter Phase 3 trial in subjects with sputum smear-positive pulmonary multidrug resistant tuberculosis (MDR-TB). This trial should assess long term outcomes of failure or relapse or death at least 6 months after all MDR-TB treatment is completed. | 3/31/2022 |
| Sirturo (bedaquiline) | As part of combination therapy for the treatment of adult and pediatric patients (12 to less than 18 years of age and weighing at least 30kg) with pulmonary multi-drug resistant tuberculosis (MDR-TB) | 8/9/2019 | PMR 1988-1: Conduct a confirmatory randomized double blind placebo controlled multicenter Phase 3 trial in subjects with sputum smear-positive pulmonary multidrug resistant tuberculosis (MDR-TB). This trial should assess long term outcomes of failure or relapse or death at least 6 months after all MDR-TB treatment is completed. | 3/31/2022 |
| Sirturo (bedaquiline) | For the treatment of, as combination therapy, adults (≥ 18 years) with pulmonary multi-drug resistant tuberculosis (MDR-TB) | 12/28/2012 | PMR 1988-1: Conduct a confirmatory randomized double blind placebo controlled multicenter Phase 3 trial in subjects with sputum smear-positive pulmonary multidrug resistant tuberculosis (MDR-TB). This trial should assess long term outcomes of failure or relapse or death at least 6 months after all MDR-TB treatment is completed. | 3/31/2022 |
| Benznidazole | For the treatment of Chagas disease (American trypanosomiasis), caused by trypanosoma cruzi, in pediatric patients 2 to 12 years of age | 8/29/2017 | PMR 3247-1: Conduct a prospective, single-arm, multicenter trial, with historical controls, to evaluate safety, efficacy and pharmacokinetics of benznidazole tablets for treatment of Chagas disease in children. | 5/31/2026 |
| Arikayce (amikacin liposome inhalation suspension) | For the treatment of mycobacterium avium complex (MAC) lung disease as part of a combination antibacterial drug regimen in patients who do not achieve negative sputum cultures after a minimum of 6 consecutive months of a multidrug background regimen therapy. As only limited clinical safety and effectiveness data for arikayce are currently available, reserve arikayce for use in adults who have limited or no alternative treatment options. This drug is indicated for use in a limited and specific population of patients. this indication is approved under accelerated approval based on achieving sputum culture conversion (defined as 3 consecutive negative monthly sputum cultures) by month 6. Clinical benefit has not yet been established | 9/28/2018 | PMR 3480-1: Conduct a randomized, double-blind, placebo-controlled clinical trial to assess and describe the clinical benefit of ARIKAYCE in patients with nontuberculous mycobacterial (NTM) lung disease caused by MAC. The trial will evaluate the effect of ARIKAYCE on a clinically meaningful endpoint, as compared to an appropriate control in the intended patient population of patients with MAC infection. | 6/30/2024 |
|
Sulfamylon (mafenide acetate) |
For use as adjunctive tropical antimicrobial agent to control bacterial infection when used under moist dressings over meshed autograpfts on excised burn wounds | 6/5/1998 | PMR 1222-1: Completion of the clinical confirmatory trial required by the Accelerated Approval regulation, as outlined in your submission dated May 13, 1998, and revised as agreed to in your facsimile of May 28, 1998. | 8/31/2010 |
- 1. "Ongoing" refers to accelerated approval (AA) applications that have not yet converted to full approval, and not to the status of the AA postmarketing requirement (PMR).
- 2. If multiple PMRs were required, the latest date is reported here. This date represents the original agreed-upon Final Study Report date and does not include any updated deadlines submitted by the Applicant.