Nabriva’s lefamulin receives FDA fast-track status to treat CABP and ABSSSI

Note* - All images used are for editorial and illustrative purposes only and may not originate from the original news provider or associated company.

Subscribe

- Never miss a story with notifications

- Gain full access to our premium content

- Browse free from any location or device.

Media Packs

Expand Your Reach With Our Customized Solutions Empowering Your Campaigns To Maximize Your Reach & Drive Real Results!

– Access the Media Pack Now

– Book a Conference Call

Leave Message for Us to Get Back

Related stories

Why Custom Tin Containers Are Reshaping Medicine & Supplement Packaging

In an industry driven by both compliance and consumer...

Sarclisa by Sanofi has EC Approval to Treat Multiple Myeloma

In order to treat multiple myeloma in adults, Sarclisa...

US Levies 15% Tariff on EU for Pharmaceutical Products

The European Union is going to pay the US...

EU-US Trade Deal Taking Shape as Pharma Tariffs Materialize

Finally, the Trump administration’s much-animated tariffs on pharmaceutical imports...

Austria-based Nabriva Therapeutics has received qualified infectious disease product (QIDP) and fast-track status designation from the US Food and Drug Administration for its lefamulin (BC 3781).

The designation has been granted for lefamulin to treat community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI).

Nabriva Therapeutics CEO Dr Colin Broom said: “There is a serious and growing public health threat as a result of the rise in increasingly difficult-to-treat bacterial infections.

“The FDA’s QIDP and fast-track designations are validation of Nabriva’s approach and underlying science to develop a truly novel antibiotic product able to address significant unmet need. Nabriva is establishing its US office and clinical development team in Philadelphia and is focused on advancing lefamulin to Phase III trials, for an initial indication in CABP.”

“There is a serious and growing public health threat as a result of the rise in increasingly difficult-to-treat bacterial infections.”

Nabriva plans to commence Phase III clinical trials for lefamulin.

Lefamulin can also be used to treat hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP), as well as in other indications, including sexually transmitted infections MDR gonorrhoea and osteomyelitis. It can also be applied in paediatric use.

Around 80% CABP cases were reported due to Streptococcus pneumoniae and Haemophilus influenza, while remaining will be caused by ‘atypical agents’ such as Mycoplasma pneumoniae, Chlamydophila pneumoniae and Legionella pneumophila.

The Gram-positive bacteria such as Staphylococcus aureus, Streptococcus pyogenes and Streptococcus agalactiae are the most common pathogens in ABSSSI.

Nabriva is engaged in the development of new class of antibiotics, the pleuromutilins, to treat patients with serious infections caused by multi-drug resistant pathogens.

Latest stories

Related stories

Why Custom Tin Containers Are Reshaping Medicine & Supplement Packaging

In an industry driven by both compliance and consumer...

Sarclisa by Sanofi has EC Approval to Treat Multiple Myeloma

In order to treat multiple myeloma in adults, Sarclisa...

US Levies 15% Tariff on EU for Pharmaceutical Products

The European Union is going to pay the US...

EU-US Trade Deal Taking Shape as Pharma Tariffs Materialize

Finally, the Trump administration’s much-animated tariffs on pharmaceutical imports...

Subscribe

- Never miss a story with notifications

- Gain full access to our premium content

- Browse free from any location or device.

Media Packs

Expand Your Reach With Our Customized Solutions Empowering Your Campaigns To Maximize Your Reach & Drive Real Results!

– Access the Media Pack Now

– Book a Conference Call

– Leave Message for Us to Get Back