Date: 2018-08-08
Type of information: Positive opinion for the granting of a Market Authorisation in the US
Product name: omadacycline
Compound: omadacycline
Therapeutic area: Infectious diseases
Action mechanism:
- antibiotic. Omadacycline is a once-daily oral and IV, well-tolerated broad spectrum investigational antibiotic being developed for use as empiric monotherapy for patients suffering from serious community-acquired bacterial infections, such as acute bacterial skin and skin structure infections, community-acquired bacterial pneumonia, urinary tract infections and other community-acquired bacterial infections, particularly when antibiotic resistance is of concern to prescribing physicians.
- Omadacycline is the first in a new class of tetracycline antibiotics known as aminomethylcyclines. It has been granted Qualified Infectious Disease Product designation and Fast Track status by theFDA for the target indications.
Company: Paratek Pharmaceuticals (USA - MA)
Disease: acute bacterial skin and skin structure infections (ABSSSI) (17-1) and community-acquired bacterial pneumonia (CABP) (14-4)
Latest news:
- • On August 8, 2018, Paratek Pharmaceuticals announced that the Antimicrobials Drug Advisory Committee of the FDA voted in favor of the approval of intravenous (IV) and oral omadacycline for the treatment of acute bacterial skin and skin structure infections (ABSSSI) (17-1) and community-acquired bacterial pneumonia (CABP) (14-4).
- As part of its recommendation, the Advisory Committee considered data from the omadacycline global development program, which included three completed Phase 3 studies evaluating the safety and efficacy of the once-daily IV and oral formulations of omadacycline for the treatment of ABSSSI and CABP. In all three studies, omadacycline met all primary and secondary efficacy outcomes designated by the FDA and was generally safe and well-tolerated. A total of nearly 2,000 adult patients received omadacycline administered once-daily as part of the clinical trials. The Advisory Committee was asked to vote on whether the data provided substantial evidence of the safety and effectiveness of omadacycline in both ABSSSI and CABP.
- The Prescription Drug User Fee Act (PDUFA) date for both new drug applications is in early October 2018.
- • On April 4, 2018, Paratek Pharmaceuticals announced that the FDA has accepted the New Drug Applications (NDAs) and granted a priority review for omadacycline. Paratek is seeking approval of omadacycline for the treatment of community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI). The two NDAs were granted priority review based on the significant unmet medical need for new agents to treat ABSSSI and CABP. In addition to Priority review, omadacycline has previously been granted Qualified Infectious Disease Product (QIDP) and Fast Track designations for the treatment of CABP and ABSSSI.
- The NDAs are supported by the company’s Phase 3 program for omadacycline, which included three pivotal registration studies: two studies in ABSSSI and one study in CABP. Omadacycline met all required FDA and European Medicines Agency (EMA) primary endpoints in each study and demonstrated a generally safe and well-tolerated profile.
- • On February 5, 2018, Paratek Pharmaceuticals announced that on February 2, 2018, it completed the submission of two New Drug Applications (NDAs) to the FDA for omadacycline. Paratek is seeking FDA approval for omadacycline for the treatment of community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI), based on the results of three successful Phase 3 pivotal studies.
Patents:
Submission of marketing authorization application USA : 2018-02-05
Submission of marketing authorization application UE:
Withdrawal of marketing authorization application USA:
Withdrawal of marketing authorization application UE:
US authorization:
UE authorization:
Favourable opinion UE:
Favourable opinion USA: 2018-08-08
Orphan status USA:
Orphan status UE:
Pediatric exclusivit _USA:
Pediatric exclusivity UE:
OTC status:
Other news:
Is general: Yes
