Patients gain early access to Pfizer's atopic dermatitis drug

People living in the UK with severe atopic dermatitis are to be given early access to Pfizer's abrocitinib following a green light by the Medicines and Healthcare products Regulatory Agency (MHRA).

The regulator has issued a positive Early Access to Medicine Scientific (EAMS) opinion allowing patients to be treated with the drug before it is officially licensed.

The drug is a JAK 1 inhibitor used to treat adult and adolescents with severe atopic eczema (also called atopic dermatitis or AD) who have failed to respond to the approved treatments or who are ineligible or intolerant to them.

In clinical trials, abrocitinib significantly reduced the severity of eczema lesions as well as reducing their extent versus placebo in patients with moderate or severe AD. In two studies, 40-45% of patients given abrocitinib 100 mg and 61-63% of those given 200mg had a meaningful reduction in EASI score compared to 10-12% of those given placebo, after 12 weeks of treatment.

Also, 24-28% of patients given abrocitinib 100 mg and 38-44% of those given 200 mg had a skin clear or almost clear of inflammation compared with 8-9% of those who were given placebo, the regulator noted.

On the safety and tolerability side, the most common side effects with abrocitinib are nausea, cold sores (herpes simplex), vomiting, upper abdominal pain, headache, dizziness, acne and an increase in blood levels of creatinine phosphokinase.

Also, as abrocitinib acts on body’s immune system, few patients may have infections such as painful skin rash with blisters (shingles), or a rapidly spreading painful rash, blisters or sores (withor without fever) known as eczema herpeticum. The drug can also cause uncommon but serious side effects including serious infections and blood clots in the lungs, legs or pelvis.

However, the MHRA said the risks of the drug can be managed and do not outweigh the benefits, and so it is being made available to patients of greatest need via the EAMS.