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13 Mar 2017

Case Study: Qualified Infectious Disease Product (QIDP) program by the US Food & Drug Administration (FDA) and it’s benefit

Qualified Infectious Disease Product (QIDP) 

  • QIDP is initiative of USFDA to incentivise the novel drug development
  • It is designed to speed the development of novel drugs against important pathogens,
  • The new QIDP designation is a significant boost to our efforts to make this drug available as quickly as possible
  • It will give us the benefit of an expedited regulatory review.
  • Whether orphan drug designation can be provided along with QIDP designation?
    Yes it can be.

Lets look into few of the case studies to understand QIDP designation in detail – 

Case Study 1:

PolyPid Ltd., an emerging clinical-stage specialty pharmaceutical company focused primarily on the development of a post-surgical anti-infective pipeline, has announced that the company’s lead product candidate, D-PLEX (Doxycycline/Polymer-Lipid Encapsulation Matrix), a secured antibiotic drug reservoir that provides a safe and effective local anti-bacterial prevention and treatment measure during surgical procedures, has been designated as a Qualified Infectious Disease Product (QIDP) by the US Food & Drug Administration (FDA).

Under the FDA’s QIDP programme, which is designed to speed the development of novel drugs against important pathogens, PolyPid will be able to take advantage of certain incentives, including FDA priority review, eligibility for fast-track status and an additional five-years of market exclusivity when marketing approval is granted for D-PLEX in preventing post-cardiac surgery sternal infection.

Case Study 2:

Pulmatrix, Inc., a clinical stage biopharmaceutical company developing innovative inhaled therapies to address serious pulmonary diseases, today announced that its drug candidate for treating fungal infections in the lungs of CF patients, PUR1900, has been designated as a “Qualified Infectious Disease Product” (QIDP) by the U.S. Food & Drug Administration.

USFDA once receive the QIDP designation request,  generally review the sponsor’s request and conclude that it meets the criteria for QIDP. Therefore we are designating your Itraconazole Inhalation Powder (PUR1900) product for inhalation use as a QIDP for….treatment of pulmonary Aspergillus infections in patients with cystic fibrosis.”

“The new QIDP designation is a significant boost to our efforts to make this drug available as quickly as possible to cystic fibrosis (CF) patients suffering from fungal lung infections,” said Pulmatrix CEO Robert Clarke, PhD. “It will give us the benefit of an expedited regulatory review. Added to our existing FDA Orphan drug designation for PUR1900, it will give us a full 12 years of market exclusivity.”

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