The latest development in what appears to be a three-way race to be the first pharmaceutical company to launch clinically-proven treatments for autoimmune hair loss, comes from Pfizer.
On 5th September 2018 Pfizer Inc. announced that the oral Janus kinase 3 (JAK3) inhibitor it is developing to treat all forms of Alopecia Areata, currently known as PF-06651600, has been designated as a Breakthrough Therapy by American regulatory body, the Food and Drug Administration (FDA).
This award was granted on the strength of the company’s Phase II clinical trial results which will be released publicly on 15th September 2018 at the European Academy of Dermatology and Venerology (EADV) Congress. Achieving this status means the development and reviews of the Phase III data, which is necessary in order to obtain the relevant FDA approvals needed to make the drug available for prescription, will be expedited in order to make it available as soon as possible.
Alopecia Areata treatment options
Alopecia Areata is an autoimmune disorder where immune cells in the body attack the hair follicles, leading to varying degrees of hair loss from hair bearing areas of the scalp and, in some cases, body. It can affect people of all ages, races and hair types and can be a one-off occurrence or may recur.
Alopecia Areata – both the name of the overarching group of conditions and that of the mildest form – causes patchy hairloss from the scalp only. This is seen as rounded bald spots and patches which may be one or many and as small as a coin or much, much bigger. When this type presents it will generally clear up of its own accord within 12 months, however, if or when this recovery will happen cannot be predicted.
Alopecia Totalis causes baldness of the scalp and may also involve the loss of facial hair, including eyelashes and eyebrows. Alopecia Universalis is the most severe form and results in a person becoming completely hairless from head to toe.
Whilst Alopecia Areata treatment options exist – and those for the scalp-only phenotype tend to have a more substantial success rate that the limited range of treatments for the more extreme iterations – they are not currently MHRA licensed nor FDA approved for the treatment of these conditions.
For children with any form of Alopecia Areata and adults with Alopecia Totalis or Universalis, it is best to contact a dermatologist or doctor as many of the therapies, such as immunotherapy, are hospital-based.
FDA Breakthrough Therapy designation
Whilst some people may feel that baldness and hair loss are insignificant cosmetic issues, particularly as losing hair isn’t physically painful, this is far from true. Studies repeatedly find that people affected by any form of Alopecia Areata can experience high levels of mental anguish, with many being clinically diagnosed with psychological disorders including depression or anxiety as a result, especially in more severe cases of baldness.
This is one of the major driving factors behind the FDA wanting to establish approved treatments to help those affected regrow their hair.
Due to this urgent need the FDA awarded two ‘Fast Track’ designations to companies developing drugs to meet these requirements, in the first half of 2018. The first went to Concert Pharmaceuticals in January 2018, then Aclaris Therapeutics in July 2018, both for their potential Alopecia Areata treatments using or based on JAK inhibition. Both have a portfolio of relevant patents for the drugs they are developing, though these seem to mostly apply to the USA and Japan.
Now Pfizer, which is the world’s largest pharmaceutical company, has been awarded a ‘Breakthrough Therapy designation’. The FDA initiated this type of award to expedite drug development and work closely with the relevant companies to ensure the reviews necessary to bring it to market happen as quickly as possible, in cases where a medication could be used ‘alone or in combination with one or more other drugs to treat a serious or life-threatening disease or condition and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints, such as substantial treatment effects observed early in clinical development’.
Pfizer has further advised in a press release that it is ‘also working with the European Medicines Agency (EMA) on the clinical development program’ for the PF-06651600 treatment.
Whether or not PF-06651600 is related to Pfizer’s existing JAK inhibitor drug, tofacitnib – brand name, Xeljanz – remains unconfirmed. However, this drug has been explored as a potential alopecia treatment by other researchers, with significant results, though concerns were raised regarding its safety profile. As a result, trials have been taking place that explore ways the deliver the drug, such as topical preparations rather than in an oral, tablet form, to help reduce these risks.
With three major players now having the FDA’s backing to help bring patients suitable treatments, proven via clinical trials to be safe, tolerable and effective, people with these conditions may have a wealth of options to choose from within the next four years.
The Belgravia Centre is an organisation specialising in hair growth and hair loss prevention with two clinics and in-house pharmacies in Central London, UK. If you are worried about hair loss you can arrange a free consultation with a hair loss expert or complete our Online Consultation Form from anywhere in the world. View our Hair Loss Success Stories, which includes the world’s largest gallery of hair growth comparison photos and demonstrates the levels of success that so many of Belgravia’s patients achieve. You can also phone 020 7730 6666 any time to arrange a free consultation.