The amount of hair resumed 80 %, $ 5 per month, and the oral medicine for hair loss was approved in the United States

Author:Kenji Bureau Time:2022.06.15

The world is bitter. On June 13, local time, an oral medicine for alopecia areata for alopecia areata was approved to be listed in the United States. This is also the first drug to treat alopecia areata in adults.

After 36 weeks after taking the medicine for more than 800 patients with severe plaques, about one -third of patients with high dose group resumed more than 80%.

Alopecia areata is a systemic immune disease that attacks its own hair follicles, causing hair to fall off any part. About 2%of people around the world have alopecia areata, about 4 million patients in China, and over 300,000 in the United States.

This drug called Baritinib is expensive. The patient group who resumed 80 % of the amount of feed on the previous description was 4 mg daily dosage. In terms of the amount of dosage, the 36 -week treatment cost approximately RMB 280,000.

Producer Lilai said that it is considering cooperating with American insurance companies to allow the American patients to pay as low as $ 5 a month; for patients who have not been insured, according to the Kenji Bureau, there may be drug purchase subsidies or gifts to give medicines. Measures, patients who can be selected for the drug donation plan will pay about $ 25 a month.

The medicine is relatively cheap in China, and it takes 19,000 yuan for the same dose for 36 weeks, which is still not cheap. However, the alopecia areata indications of the medicine are not approved in China. Lilly revealed to the Jianzhi Bureau that it has applied to the State Drug Administration. The previous clinical trial subjects include Asians, so the approval of alopecia areata indications in China may be accelerated.

What is exciting is that China has many hair loss drugs clinically.

"One arrow more carved"

The Barride's alopecia areata is a typical "old medicine and new use", which is the fourth indication approved by the drug in the United States.

In May this year, the European Pharmaceutical Administration (EMA) Pharmaceutical Products Committee (CHMP) issued a positive review opinion to recommend the approved oral Baritinib for the treatment of heavy alopecia areata for adults, and it is expected to make a decision soon.

Baritinib was originally developed by the United States Incyte. In December 2009, Incyte and Lilly reached an agreement on the medicine. Lilly was responsible for global development and sales, and Sett only reserved the co -sales right of the US market.

Initially, Baritinib was used for the treatment of moderate to severe rheumatoid arthritis. So far, more than 70 countries have approved the indications. In February 2017, the medicine was approved in the EU; it was approved in the United States on May 31, 2018. Earlier, FDA had worried about the security of Baritinib and demanded additional clinical data.

In May 2022, the FDA approved Baritinib for the treatment of new crown -related hospitalization patients. It was also the first new crown immunode treatment drug approved by the FDA. So far, more than 50 countries have approved this indication.

In the European Union and Japan, the indications of Baritinib also include moderate to severe dermatitis (eczema) therapy.

However, Baritinib is not omnipotent. In February 2022, Lilly announced the termination of the development of Baritinib in treating systemic lupus erythematosus indications.

It is worth noting that Baritinib was approved in China for the treatment of rheumatoid arthritis for adult patients. In its instructions, adverse drug reactions include low -density lipoprotein cholesterol, upper respiratory tract infection, and headache.

Later

The alopecia areata market is not large. Investment banking company Mizuho Securities predicts that by 2030, the US market will be about $ 259 million and the European market will be about $ 154 million.

On the small track, the competitors are very crowded, and at least 4 alopecia areata drugs are on the road.

On May 23, the United States Concert announced that its oral drug CTP-543 was a clinical phase 3 of adults to severe alopecia areata: 40%of the scalp coverage rate of 40%of the scalp has reached 80%. The company claims that CTP-543 is expected to become the best product for treating alopecia areata, and intends to submit a listing application in the first half of 2023.

Pfter's alopecia areata oral drugs PF-06651600 are also in the third phase of the United States. The drug also obtained the qualifications for breakthrough therapy of the China State Drug Administration's Pharmaceutical Review Center for treatment of patients over the age of 12.

On April 19, 2022, Ruishi Bio, a subsidiary of Hengrui Pharmaceutical, announced that its immunotherapy SHR0302 was used to treat alopecia areata clinical trials. medicine. Earlier, the clinical trials of random, double -blindness, placebo control, and international multi -centers showed that after 24 weeks of treatment, patients could significantly promote hair regeneration and improve the quality of life of patients.

The alopecia areterflowing drugs of Zezhe Bio have entered a clinical phase 3 in China, and in the United States, it is the application stage of the new drug clinical trial. On May 9, 2022, at the performance briefing held by Zezhe Pharmaceutical, Zeye Pharmaceutical announced that the medicine treatment of the medicine was good, and the global unparalleled alopecia areata treatment drugs were currently approved.

The above four alopecia areata drugs are similar to the Baritininib in Lili Lilly, both of which are JAK kinase inhibitors, which can block the activity of one or more specific enzyme families, thereby interfereb the ways that cause inflammation.

Patients' more androgen hair loss (commonly known as "male loses") drugs are also competitive hotspots.

The pioneering pharmaceutical treatment of male male and male drug Furien has developed two clinical clinics in the United States, and completed the first patient's admission and administration on February 28 this year;China Phase 3 clinical trials were carried out in 26 centers in China, and the first patient was admitted to the group and administration.One month before, the second clinical trial of the second phase of the Chinese pharmaceutical treatment of the female male has also completed the first patient's admission and administration.The second phase of clinical trial applications for the treatment of male medicine treatment with Rui Medicine also obtained the FDA consent of the United States earlier this year.This is a monoclonal antibody drug that targeted the prolactin receptor developed with Bayer, Germany.

It is unknown to the bald battlefield deer.

Writing | Sun Tao

Edit | Jiang Yun

Operation | Twenty -thirty

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