Home » News » PLC News » Motif Bio plc FDA cannot approve the NDA
Motif Bio plc

Motif Bio plc FDA cannot approve the NDA

Motif Bio plc (LON: MTFB), a clinical-stage biopharmaceutical company specialising in developing novel antibiotics, has announced today that the Company has received a Complete Response Letter from the U.S. Food & Drug Administration regarding the New Drug Application (NDA) for iclaprim for the treatment of acute bacterial skin and skin structure infections (ABSSSI). The CRL states that the FDA cannot approve the NDA in its present form and indicates that additional data are needed to further evaluate the risk for liver toxicity before the NDA may be approved. Motif Bio plans to request a meeting with the FDA as soon as possible to discuss potential options to address the deficiencies.

Graham Lumsden, Chief Executive Officer of Motif Bio plc, said:

“We are disappointed for patients and providers seeking an alternative antibiotic to treat ABSSSI. We intend to request a meeting with the FDA, which typically should occur within approximately 30-45 days, to discuss the CRL. We look forward to working with the Agency to discuss options to advance iclaprim towards approval.”

At 31 December 2018, the Company had cash of $12.3 million and $15 million of debt drawn from its Hercules loan facility. The Company is financed into the second quarter of 2019 but will need to raise capital in the near term.

If approved for the ABSSSI indication as a New Chemical Entity, iclaprim will be eligible for 10 years of market exclusivity in the U.S. from the date of first approval, under the Generating Antibiotic Incentives Now Act. In addition, Motif is building a patent estate to provide additional protection for iclaprim and has two U.S. method of use patents issued that will expire in 2037.

Join us on our new LinkedIn page

Follow us on LinkedIn