Regeneron Pharmaceuticals, Inc. (REGN) Receive Positive CHMP’s Opinion for Dupixent(R)


Featured Company News – Regeneron and Sanofi Receive Positive CHMP’s Opinion for Dupixent(R)

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What is Atopic Dermatitis (AD)?

AD, also known as atopic eczema is a form of eczema, a chronic inflammatory disease with symptoms such as a rash on the skin. In cases of moderate to severe AD, patients get rashes on most parts of their body, with extreme, persistent itching and skin dryness, cracking, redness, crusting, and oozing. Itchiness is the most troublesome symptom that can severely weaken patients. At times, people with moderate to severe AD also show symptoms of disrupted sleep, increased anxiety, and depression.

In the United Kingdom, nearly 1.5 million (i.e. 3%) adults have AD. Within UK’s population, it is assessed that there are about 14 adults per 100,000 with moderate AD and 6 adults per 100,000 with severe AD who may be eligible for treatment with Dupixent®.

How does Dupixent® Cure AD?

Dupixent® is an investigational fully human monoclonal antibody that has been specially designed to restrain overactive signaling of two key proteins IL-4 and IL-13. IL-4 and IL-13 are the main drivers of the inflammation in AD. Regeneron and Sanofi Genzyme, the specialty care global business unit of Sanofi, are jointly developing Dupixent®.

If this drug is approved, it will be available in a pre-filled syringe for self-administration by a patient. It is to be taken as a subcutaneous injection every other week after an initial loading dose. It can be used with or without topical corticosteroids.

In the US, Dupixent® has been approved for the treatment of adults who have moderate to severe AD and whose disease is not properly controlled by topical prescription therapies, or in cases when those therapies are not advisable.

Some views from the industry

Dr. Mahreen Ameen, consultant dermatologist, Royal Free London NHS Foundation Trust stated that people suffering from AD live with a life-long condition that has intolerable symptoms impacting all aspects of their lives. He mentioned that doctors have had very few options to treat patients with this disease until now. He believes if Dupixent® is approved, it will be a greatly welcomed treatment option.

Peter Kuiper, General Manager UK & Ireland at Sanofi Genzyme also had a similar opinion. He agreed that AD is a disease that can have a detrimental impact on a person’s quality of life, causing physical discomfort and often emotional distress. He applauded CHMP’s positive recommendation for Dupixent®. He said it is an important step for introducing an innovative treatment option for patients who are suffering from AD.

European Commission (EC) decision pending

Going by the common trend, the European Commission’s (EC) final decision on the Marketing Authorization Application (MAA) for Dupixent® in the European Union is expected in the coming months. The CHMP’s opinion is based on studies from the global LIBERTY AD clinical trial program, which includes SOLO 1, SOLO 2, SOLO-CONTINUE, CHRONOS, and CAFÉ. These studies have included data from approximately 3,000 adult patients who had moderate to severe AD that was not properly controlled by topical prescription therapies or immunosuppressants such as cyclosporine, or in cases when those therapies were not advisable. In clinical trials, the common side effects noted were injection site reactions, viral infections such as herpes affecting the mouth, dry eye, and similar symptoms affecting the eye.


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