Sanofi’s blockbuster-tipped Dupixent set for European launches

Sanofi’s new atopic dermatitis treatment Dupixent has gained EU approval, setting it up for a launch across key European markets.

Dupixent (dupilumab) is tipped to be the market leader among a new generation of inflammation drugs, analysts Evaluate Pharma forecasting it will hit sales of nearly $5 billion by 2022.

This is based on the drug ‘s strong performance in clinical trials improving atopic dermatitis (AD) in moderate-to-severe patients, where it is the first systemic drug approved for the condition.

The IL-4 and IL-13 targeting antibody is administered as a subcutaneous injection every other week after an initial loading dose, and can be used with or without topical corticosteroids.

The drug has got off to a flying start in the US market, achieving rapid uptake since its launch in April, despite is high $37,000 price tag.

The US launch has been a great success for Sanofi and its US marketing partner Regeneron, and it hopes to achieve similar success in Europe.

Sanofi plans to launch in Germany first, but is also laying the groundwork in the UK. The company isn’t disclosing what its European prices are yet, although they are certain to be considerably lower than the US cost.

The potential AD market in Europe is very large: the most common form of eczema, around 1.5 million adults in the UK alone have the condition. Sanofi’s UK affiliate says an estimated 14 adults per 100,000 within the general population with moderate AD and 6 adults per 100,000 with severe AD may be eligible for treatment with the drug.

In addition to the severe itching and discomfort in the skin, the worst affected patients can experience disrupted sleep, and increased anxiety and depression.

The new product follows an EU approval in June for another Sanofi inflammation treatment, new rheumatoid arthritis treatment Kevzara (sarilumab).  This makes the company a substantial player in the field, one it which it previously had no presence.

UK market access

Peter Kuiper, general manager UK & Ireland at Sanofi Genzyme said the European Commission approval of Dupixent was a milestone for patients affected by the condition.

“We are already working with the authorities in the UK with the goal of making dupilumab available on the NHS as quickly as possible for those who need it,” he said.

It’s likely that patients with the most severe disease will be the first to receive Dupixent in the UK and other EU markets.

England’s cost effectiveness watchdog NICE is in the early stages of its appraisal of Dupixent, having begun the process in August. Based on previous timelines for similar drugs, Sanofi may have to wait until mid-2018 before NICE publishes its draft opinion.

Whether this will be a positive recommendation or a rejection will depend greatly on what price Sanofi puts forward in the first instance.

The drug has got a small head start in England, thanks to it being accepted into the Early Access to Medicines Scheme (EAMS) in March this year.

EAMS allows doctors to prescribe innovate new treatments before they gain EU marketing approval. This helps meet patients needs, but also gives new products a toehold in England’s hard-to-crack market.

Sanofi says there has been more than 200 applications to receive the drug under the system, which ceases once a drug gains marketing approval.

The scheme also obliges NHS England to implement final NICE guidance on EAMS medicines within 30 days, much faster than the usual 90 days.

However EAMS doesn’t place NICE under any obligation to recommend a drug, and Sanofi is likely to face demands for a confidential Patient Access Scheme discount, as is now a matter of course.

Potential in asthma

The drug is also set to gain further indications in further inflammation-related diseases, most notably asthma.

It just scored a major hit in phase 3 trials in asthma, and Sanofi and its US partner Regeneron plan to submit the drug to the FDA for this use by the end of 2017.

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