FDA approves new Dupixent prefilled pen

23 Jun 2020

The prefilled pen supports more convenient self-administration for patients with chronic type 2 inflammatory diseases.

Regeneron Pharmaceuticals and Sanofi have received FDA approval for a 300 mg single-dose prefilled pen for Dupixent (dupilumab).

FDA approves new Dupixent prefilled pen
FDA approves a 300 mg single-dose pre-filled pen for Dupixent. (Image: courtesy of Regeneron Pharmaceuticals.)

The prefilled pen is approved for all Dupixent indications in patients aged 12 years and older, which includes use in certain patients with atopic dermatitis, asthma and chronic rhinosinusitis with nasal polyposis (CRSwNP), for at-home administration.

This new prefilled pen is expected to provide patients with a more convenient option for administering Dupixent.

The 300 mg pre-filled pen, which is expected to be available in the US in the third quarter of 2020, features a hidden needle and single-press auto-injection, along with visual and audio feedback to help with administration.

Regeneron and Sanofi are working with the FDA to provide additional data they require to complete their review of the 200 mg pre-filled pen. The pre-filled syringe continues to be available in both 200 mg and 300 mg doses for use in a clinic or at home by self-administration. Both methods of administration require training by a healthcare professional.

Dupixent is a fully-human monoclonal antibody that inhibits the signaling of the interleukin-4 (IL-4) and interleukin-13 (IL-13) proteins, and is not an immunosuppressant. Data from Dupixent clinical trials have shown that IL-4 and IL-13 are key drivers of the type 2 inflammation that plays a major role in atopic dermatitis, asthma and CRSwNP.

Read More

Related news

SGS joins with Biophytis to launch international trial of COVID-19 related respiratory failure treatment

SGS joins with Biophytis to launch international trial of COVID-19 related respiratory failure treatment

7 Jul 2020

The CRO will undertake this clinical trial at multiple sites worldwide, starting at the AZ Sint Maarten hospital in Mechelen, Belgium.

Read more 
Regeneron wins $450 million US government manufacturing agreement for anti-viral antibody cocktail

Regeneron wins $450 million US government manufacturing agreement for anti-viral antibody cocktail

7 Jul 2020

The company began scaling up manufacturing of REGN-COV2 at business risk earlier this year to ensure the immediate availability of the product if clinical trials prove successful.

Read more 
Croda bolsters position in life sciences with the acquisition of Avanti Polar Lipids

Croda bolsters position in life sciences with the acquisition of Avanti Polar Lipids

6 Jul 2020

The transaction will more than double Croda’s R&D capability in drug delivery.

Read more 
Rentschler Biopharma and Vetter team up to simplify processes

Rentschler Biopharma and Vetter team up to simplify processes

6 Jul 2020

Companies agree that the key to tackling drug development complexity is collaboration.

Read more 
Cambrex increases flexible manufacturing capacity at Karlskoga, Sweden facility

Cambrex increases flexible manufacturing capacity at Karlskoga, Sweden facility

6 Jul 2020

An investment of $3.6 million will cover the installation of a new production line to keep pace with continued growth in commercial-scale API manufacturing.

Read more 
iNova Pharmaceuticals announces the launch of iPitch 2020

iNova Pharmaceuticals announces the launch of iPitch 2020

3 Jul 2020

Following on from the success of the inaugural iPitch launch in 2019, iNova Pharmaceuticals is delighted to announce the launch of a new round of iPitch challenges for 2020.

Read more 
Ajinomoto introduces fast track platform for drug product manufacturing

Ajinomoto introduces fast track platform for drug product manufacturing

30 Jun 2020

AJILITY is designed to speed novel or existing therapeutics from development to manufacturing and into the clinic.

Read more 
CPhI Worldwide to transform into Festival of Pharma digital experience

CPhI Worldwide to transform into Festival of Pharma digital experience

30 Jun 2020

The 10-day event will feature an interactive digital marketplace for sourcing products and services, enhanced matchmaking for connecting with new and existing partners, and world-renowned speakers.

Read more 
Catalent expands beauty and plant-based consumer health softgel capabilities

Catalent expands beauty and plant-based consumer health softgel capabilities

30 Jun 2020

Two company sites - one in Canada, the other in Brazil - receive new softgel encapsulation lines to service local customer demand.

Read more 
Stevanato Group pledges to provide glass vials for potential COVID-19 vaccines

Stevanato Group pledges to provide glass vials for potential COVID-19 vaccines

29 Jun 2020

The company agrees to provide CEPI with 100 million glass vials, which can store 20 doses per vial (2 billion doses in total).

Read more