iclaprimTreatment for Skin and Structure Infection
FDA Grants Fast Track Designation for Iclaprim
September 3, 2015 -- Motif Bio plc (AIM: MTFB), the clinical stage biopharmaceutical company specialising in developing novel antibiotics, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for iclaprim intravenous (IV) to treat Acute Bacterial Skin and Skin Structure Infections (ABSSSI) and Hospital Acquired Bacterial Pneumonia (HABP).
The FDA’s Fast Track programme is designed to aid the development and accelerate the review of new drugs that are intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs. Drugs with Fast Track designation typically qualify for priority review, which expedites the FDA review process and market approval. Companies that receive Fast Track designation for a drug benefit from more frequent interactions with the FDA during clinical development and can submit completed sections of their New Drug Application (NDA) on a rolling basis.
Graham Lumsden, Chief Executive Officer at Motif, said: “This is excellent news for Motif and comes on the back of the QIDP designation for iclaprim in late July. This Fast Track designation means we will benefit from greater FDA support and that we remain on our Phase III development timeline.”
The FDA has previously designated iclaprim for the treatment of ABSSSI and HABP as a Qualified Infectious Disease Product (QIDP). The QIDP designation will make iclaprim eligible to benefit from certain incentives as provided under the Generating Antibiotic Incentives Now (GAIN) Act. These incentives include FDA priority review, eligibility for fast-track status, and if ultimately approved by the FDA, iclaprim would be eligible for an additional five-year extension of Hatch-Waxman exclusivity, for a total of 10 years of market exclusivity, starting from the date of NDA approval.
About Motif Bio plc
Motif is a clinical stage biopharmaceutical company, which specialises in developing novel antibiotics designed to be effective against serious and life-threatening infections caused by multi-drug resistant bacteria.
Iclaprim is being developed for the treatment of the most common and serious bacterial infections such as acute bacterial skin and skin structure infections (ABSSSI) and hospital acquired bacterial pneumonia (HABP), including those caused by resistant strains such as MRSA (methicillin-resistant Staphylococcus aureus) and MDRSP (multi-drug resistant Streptococcus pneumoniae) that have become prevalent in patients in both the community and hospital settings.
The Company is in discussions with pharmaceutical companies and universities to build a pipeline of innovative antibiotics targeting Gram-positive and Gram-negative bacteria.
Source: Motif Bio plc
Posted: September 2015
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- Motif Bio Announces FDA Acceptance of New Drug Application With Priority Review for Iclaprim for Treatment of Acute Bacterial Skin and Skin Structure Infections - August 14, 2018
- Motif Bio Submits NDA for Iclaprim - June 14, 2018
- First Patient Dosed in Iclaprim Phase 3 Trials to Treat Skin Infections - March 2, 2016
- FDA QIDP Designation for Motif’s Lead Antibiotic Candidate Iclaprim for ABSSSI - July 22, 2015
- FDA Issues Complete Response Letter for Iclaprim - January 20, 2009
- Arpida Comments on FDA's Anti-infective Drugs Advisory Committee Outcome - November 21, 2008
- Arpida Announces Review of Iclaprim NDA by FDA Advisory Committee in November 2008 - October 14, 2008
- Arpida Announces FDA Acceptance of the Iclaprim New Drug Application - May 16, 2008
- Arpida Submits New Drug Application for Intravenous Iclaprim for Treatment of Skin Infections - March 19, 2008
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