Alopecia Areata Treatment Get FDA Breakthrough Therapy Status

Alopecia areata is considered the most severe type of hair loss experienced. At present, there is no cure for the condition which affects millions of people. However, Lilly’s Olumiant has recently been given breakthrough status by the FDA for its potential new alopecia areata drug option.

The breakthrough status was provided for the JAK inhibitor, Olumiant in the treatment of alopecia areata. The treatment is most commonly used to treat arthritis patients, but it has shown promising results in studies for alopecia areata.

Here, we’ll look at the new potential treatment for the condition and what it could mean for patients.

Why has Lilly’s alopecia areata drug given breakthrough status?

The breakthrough status given to Lilly’s Olumiant was granted after the success of its stage 2 trial. The treatment was first approved for use in patients with rheumatoid arthritis back in 2018 in the US and is currently used in 6 different countries.

However, Olumiant hasn’t achieved the level of success it could have done due to the fact it was only approved in low 2mg doses. There are also warnings on its label for the risk of blood clots, infections and cancer.

The treatment was discovered to have potential benefits to Alopecia Areata patients in its current trials. These were carried out with higher 4mg doses of the drug and have so far revealed promising results.

Understanding the latest studies

The latest ongoing trial is now in its stage 3 process. The FDA granted approval of Olumiant after the stage 2 test results were revealed.

Patients with severe or very severe alopecia areata were given the drug for 36 weeks. There were 725 patients involved in the study. Some were given a 2mg dose, others were given a 4mg dose and then a final group were given placebo treatment.

Interim results reveal that there were no additional safety implications of taking the higher dose. Only a small number of mild side effects were identified, such as acne and upper respiratory tract infections.

Stage 3 has now begun and it includes an additional pivotal study made up of 476 patients. If it turns out to show positive results, the findings will be released in 2021.

What is alopecia areata?

Alopecia areata is an auto-immune condition, caused when the immune system starts attacking its own cells. It tends to start during childhood, though it can occur at any age.

The condition causes patches of hair loss and in severe cases, total baldness. There is no cure for this type of hair loss, though there are some effective treatments to manage it. The majority of cases are treated with strong corticosteroid drugs which are known to have side effects when used in the long term. So, this latest study could prove life-changing if Olumiant proves to be a successful treatment option.

There are different types of hair loss and Alopecia Areata is known to be the most severe. It can cause a lot of distress to patients, so a new potential treatment would prove life-changing.