FDA Qualified Infectious Disease Product Designations

Pharmaceutical Approvals Monthly introduces a new feature tracking anti-infective product candidates that have received a Qualified Infectious Disease Product Designation from FDA. QIDP status was introduced in FDASIA to encourage development of treatments for serious or life-threatening infections caused by bacteria or fungi.

A new feature in Pharmaceutical Approvals Monthly tracks products awarded Qualified Infectious Disease Product Designation by FDA. QIDP status is a provision of the Generating Antibiotic Incentives Now (GAIN) Act, which became a title of the FDA Safety and Innovation Act (PDUFA V) signed into law in July 2012. It provides incentives such as eligibility for fast-track and priority review, as well as an additional five years of exclusivity to be added to other exclusivities, such as orphan designation. It embraces treatments for diseases caused by antibacterial- or antifungal-resistant pathogens, including new or emerging pathogens or diseases. To be considered, sponsors must provide clinical evidence the antibiotic/antifungal can treat the specified pathogen in a specific indication.

Sponsor Announcement Date	Product	Indication	Status
Melinta Therapeutics (formerly known as Rib-X Pharmaceuticals) 9/17/2012	Delafloxacin – novel fluoroquinolone in oral and intravenous formulations designed for first-line use in hospitals prior to availability of a specific diagnosis	Acute bacterial skin and skin structure infections caused by Gram-negative and Gram-positive bacterial infections, including methicillin-resistant Staphylococcus aureus; uncomplicated gonorrhea	Phase III in gonorrhea – oral Phase III in ABSSSI – I.V. Phase III testing step-down from I.V. to oral in ABSSSI
Melinta Therapeutics (formerly known as Rib-X Pharmaceuticals) 10/10/2012	Radezolid – next-generation oxazolidinone in oral and intravenous formulations	Acute bacterial skin and skin structure infections; community-acquired bacterial pneumonia	Phase II completed with oral formulation
Durata Therapeutics 11/5/2012	Dalvance (dalbavancin) – an intravenous second-generation semi-synthetic lipoglycopeptide with a longer half-life than vancomycin	Acute bacterial skin and skin structure infections caused by susceptible Gram-positive microorganisms, including methicillin-resistant Staphylococcus aureus	NDA under priority review with 5/26/2014 action date; advisory committee review scheduled for 3/31/2014
Cubist Pharmaceuticals 12/6/2012	Ceftolozane/tazobactam (CXA-201) – novel cephalosporin with well-established beta lactamase inhibitor in intravenous form	Complicated intra-abdominal infections	NDA for cUTI/cIAI anticipated 1H 2014 Fast-track designation
Cubist Pharmaceuticals 12/6/2012	Surotomycin (CB-315) – an oral rapidly bactericidal lipopeptide	Clostridium difficile-associated diarrhea	Phase III Fast-track designation
Paratek Pharmaceuticals 1/3/2013	Omadacycline (PTK 0796) – tetracycline-derived broad-spectrum antibiotic in intravenous and oral formulations for use as first-line monotherapy where antibiotic resistance is a concern	Acute bacterial skin and skin structure infections; community-acquired bacterial pneumonia	Phase III ready with special protocol assessments in place
Cubist Pharmaceuticals (Cubist gained tedizolid with its acquisition of Trius Therapeutics) 1/7/2013	Tedizolid (TR-701) – a second-generation oxazolidinone in intravenous and oral formulations	Acute bacterial skin and skin structure infections; hospital-acquired/ventilator-associated bacterial pneumonia caused by serious Gram-positive infections, including those caused by methicillin-resistant Staphylococcus aureus	ABSSSI NDA under priority review with 6/20/2014 action date; advisory committee review scheduled for 3/31/2014 HABP/VAPB Phase III planned 1Q 2014
Furiex Pharmaceuticals 2/25/2013	Avarofloxacin (JNJ–Q2) – broad spectrum fluoroquinolone antibiotic in intravenous and oral formulations	Acute bacterial skin and skin structure infections; community-acquired pneumonia	Phase III ready Fast-track designation
Cubist Pharmaceuticals 2/28/2013	Ceftolozane/tazobactam (CXA-201) – novel cephalosporin with well-established beta lactamase inhibitor in intravenous form	Hospital-acquired bacterial pneumonia; ventilator-associated bacterial pneumonia; complicated urinary tract infections caused by Gram-negative bacteria, including those caused by multi-drug resistant Pseudomonas aeruginosa	cUTI/cIAI NDA anticipated 1H 2014 HABP/VABP Phase III planned 1H 2014 Fast-track designation for all three indications
Paratek Pharmaceuticals 5/1/2013	Omadacycline (PTK 0796) – tetracycline-derived broad-spectrum antibiotic in intravenous and oral formulations for use as first-line monotherapy where antibiotic resistance is a concern	Complicated urinary tract infections	Phase II planned
Insmed 6/28/2013	Arikace (liposomal Amikacin for inhalation) – a form of the antibiotic enclosed in nanocapsules of lipid, or liposomes, which prolongs the release of Amikacin in the lungs while minimizing systemic exposure	Non-tuberculous mycobacterial lung infections	Phase II Fast-track designation
Tetraphase Pharmaceuticals 7/15/2013	Eravacycline – a fully synthetic new broad-spectrum antibiotic in intravenous and oral formulations for use as empiric monotherapy for treatment of multi-drug resistant infections, including multi-drug resistant Gram-negative infections	Complicated intra-abdominal infection; complicated urinary tract infection	cUTI Phase III cIAI Phase III
MerLion Pharmaceuticals 8/22/2013	Finafloxacin – an atypical fluoroquinolone in oral and intravenous formulations	Complicated urinary tract infections, including pyelonephritis; complicated intra-abdominal infections; acute bacterial skin and skin structure infections	Phase II in cUTI Fast-track designation
Cempra 9/6/2013	Solithromycin (CEM-101) – an oral and I.V. fourth-generation macrolide/fluoroketolide	Community-acquired bacterial pneumonia	Phase III oral Phase III I.V. to oral
Forest Laboratories/AstraZeneca 9/12/2013	Ceftazidime/avibactam (NXL104) – broad-spectrum cephalosporin/novel beta-lactamase inhibitor	Complicated intra-abdominal infections; complicated urinary tract infections; hospital-acquired bacterial pneumonia/ventilator-associated bacterial pneumonia caused by Gram-negative infections, including extended-spectrum beta-lactamases and Klebsiella pneumoniae carbapenemases that are resistant to existing therapies	Phase III cIAI Phase III cUTI
Debiopharm Group (Debiopharm acquired AFN-1252 from Affinium) 11/12/2013	AFN-1252 – a staphylococcal-specific antibiotic that inhibits FabI	Acute bacterial skin and skin structure infections	Phase II completed for oral formulation
The Medicines Company 11/12/2013	Oritavancin – intravenous semisynthetic lipoglycopeptide analogue of vancomycin	Acute bacterial skin and skin structure infections caused by susceptible Gram-positive bacteria, including methicillin-resistant Staphylococcus aureus	NDA under priority review with an 8/6/2014 action date
Basilea Pharmaceutica/Astellas Pharma 12/3/2013	Isavuconazole – broad-spectrum antifungal in oral and intravenous formulations	Invasive aspergillosis	Phase III completed Orphan drug designation Fast-track designation
Savara Pharmaceuticals 12/10/2013	AeroVanc – proprietary inhaled powdered form of vancomycin	Persistent methicillin-resistant Staphylococcus aureus lung infection in cystic fibrosis patients	Phase II Fast-track designation
Microbion 12/13/2013	BisEDT Antimicrobial Gel – novel antimicrobial agent with activity against a broad spectrum of Gram-positive and Gram-negative antibiotic-resistant bacteria, as well as against microbial biofilms	Antibiotic-resistant orthopedic implant infections	Phase II ready
TaiGen Biotechnology 12/23/2013	Taigexyn (nemonoxacin) – an NCE broad spectrum antibiotic in oral and intravenous formulations	Community-acquired bacterial pneumonia; acute bacterial skin and skin structure infections	Two Phase II trials completed in CABP Fast-track designation
Cardeas Pharma 1/8/2014	Amikacin Fosfomycin Inhalation System – combines two investigational drug components and the investigational eFlow inline nebulizer system	Adjunct therapy to I.V. antibiotics in mechanically ventilated patients with Gram-negative bacterial pneumonia, including patients infected with multi-drug-resistant Gram-negative bacteria or those co-infected with Gram-positive bacteria such as methicillin-resistant Staphylococcus aureus	Phase II Fast-track designation
The Medicines Company (TMC gained Carbavance with its acquisition of Rempex) 1/13/14	Carbavance – novel beta-lactamase inhibitor (RPX7009) with a carbapenem in intravenous form	Complicated urinary tract infection; complicated intra-abdominal infection; hospital-acquired bacterial pneumonia; ventilator-associated bacterial pneumonia; febrile neutropenia	Phase I completed
Scynexis 2/21/2014	SCY-078 (formerly MK-3118) – oral and parenteral glucan synthase inhibitor	Invasive Candidiasis, including Candidemia, and invasive Aspergillosis	Entering Phase II
Basilea Pharmaceutica/Astellas Pharma 2/27/2014	Isavuconazole – broad-spectrum antifungal in oral and intravenous formulations	Invasive mucormycosis (also known as zygomycosis)	Phase III completed Orphan drug designation
Actelion 2/27/2014	Cadazolid – oral inhibitor of C. diff protein synthesis	Clostridium difficile-associated diarrhea	Phase III Fast-track designation