"Yaodu Yaowen" Abrocitinib was first approved for the treatment of atopic dermatitis, and K drug was approved for the first-line treatment of esophageal cancer...

Reply to receive the full version of the report in the public account: 2021.
09.
04-2021.
09.
101 Global new drug approval status 1.
Abrocitinib was awarded the first batch of MHRA for the treatment of atopic dermatitis in the world! On September 9, 2021, Pfizer announced that the Medicines and Health Products Administration (MHRA) of the United Kingdom has approved Abrocitinib as an oral JAK1 inhibitor for adults and adolescents over 12 years of age who are suitable for systemic treatment with moderate to severe atopic dermatitis (AD ), the approved recommended doses are 100 mg and 200 mg once a day
.

This is the first time the therapy has been approved in the world
.

Abrocitinib has obtained positive results in multiple phase 3 clinical trials
.

In the randomized, double-blind, placebo-controlled Phase 3 clinical study of JADE MONO-1, after 12 weeks of treatment, compared with the placebo group, 43.
8% and 23.
7% of patients had skin symptoms that reached or nearly completely disappeared ( IGA score 0/1), while the value in the placebo group was 7.
9%
.

In the treatment group, 62.
7% and 39.
7% of patients had eczema area and severity index improved by at least 75% from baseline (EASI 75), compared to only 11.
8% in the placebo group
.

Atopic dermatitis is a chronic skin disease characterized by skin inflammation and skin barrier defects.
It is characterized by red/purple spots, itching, induration/papules, and exudate/scabs
.

It is also one of the most common chronic recurrent childhood skin diseases, affecting approximately 10% of adults and approximately 20% of children worldwide
.

Many moderate-to-severe patients are poorly controlled and require additional treatment options to relieve symptoms
.

1.
The medical device combination TRUDHESA™ for migraine treatment has been approved by the FDA for marketing! On September 3, 2021, Impel NeuroPharma, Inc.
announced that the US Food and Drug Administration (FDA) approved dihydroergotamine mesylate nasal spray (0.
725 mg per spray) for adults (with or without aura) Acute treatment of migraine
.

Dihydroergotamine mesylate (DHE) was approved for the treatment of migraine in 1946 and has a history of more than 70 years
.

Migraine is the second most common cause of disability in the world and the most common cause of disability in young women
.

It is characterized by recurrent moderate to severe headaches, accompanied by nausea, vomiting, and sensitivity to light and sound
.

There is evidence that 80% of migraine patients experience gastroparesis and delayed gastric emptying, which may delay or reduce the absorption of oral medications
.

In addition, more than 70% of migraine sufferers experience nausea, and nearly 30% experience vomiting
.

The American Headache Association guidelines recommend non-oral treatment for patients with limited or no response to oral medications
.

TRUDHESA™ is a drug/medical device combination product that contains a bottle of DHE and a POD sprayer
.

By using Impel's proprietary precision olfactory transmission (POD®) technology, dihydroergotamine mesylate (DHE) is gently and quickly delivered to the blood through the upper nasal cavity, which is rich in blood vessels
.

TRUDHESA™ bypasses the intestinal and potential absorption problems and provides rapid, continuous and consistent relief of symptoms without the need for injections or infusions, even when administered several hours after the onset of migraine
.

This approval is based on the positive results of the pivotal Phase 3 clinical trial STOP301, which included 5650 migraine attacks
.

The results of this trial indicate that TRUDHESA™ is generally well tolerated, and exploratory efficacy results show that it can provide rapid, sustained, and consistent symptom relief
.

Oral acute treatment usually needs to be taken within 1 hour after the onset of migraine to achieve the best effect, and TRUDHESA™ can provide consistent efficacy even when administered several hours after the onset
.

Specifically, more than one-third of patients (38%) reported no pain after treatment, two-thirds of patients (66%) had pain relief, and more than half of patients (52%) reported no pain after the first use of TRUDHESA™ I got rid of the most annoying migraine symptoms within two hours
.

One in six patients (16%) showed pain relief as early as 15 minutes after the administration
.

Among patients who had no pain within 2 hours, 93% remained pain-free within 24 hours, and 86% remained pain-free within 2 days
.

The vast majority of patients (84%) reported that TRUDHESA™ is easy to use and superior to their current treatments
.

2 Domestic drug approval/development trends 2.
1 Domestic new drug approval 2.
1.
1 Innovative/improved new drug approval No innovative/improved new drug was approved this week
.

1.
K drug is approved for the first-line treatment of esophageal cancer, and the eighth approved indication in China! On September 6, 2021, Merck announced that the PD-1 inhibitor pembrolizumab has been approved by the National Medical Products Administration (NMPA) in combination with platinum and fluorouracil chemotherapy drugs for locally advanced unresectable or metastatic esophagus or First-line treatment for patients with gastroesophageal junction cancer
.

This is also the eighth indication for drug K approved in China
.

The seven indications that have been approved in China earlier include first- and second-line treatments for melanoma, non-small cell lung cancer, head and neck squamous cell carcinoma, colorectal cancer, and esophageal cancer
.

The approval of the new indication for drug K is based on data from the key global phase III clinical study KEYNOTE-590
.

This randomized, placebo-controlled, double-blind, phase 3 study, conducted in 168 medical centers in 26 countries, recruited untreated locally advanced, unresectable or metastatic esophageal cancer or Siewert type 1 gastroesophageal junction cancer Adult patients (not limited to PD-L1 status)
.

A total of 749 patients were randomized 1:1 to receive pembrolizumab combined with chemotherapy or placebo combined with chemotherapy
.

Studies have shown that pembrolizumab combined with chemotherapy in the first-line treatment of patients with advanced esophageal cancer reduces the risk of death by 27% and the risk of disease progression or death by 35% compared with chemotherapy, and can benefit regardless of the patient's histology
.

It is worth noting that KEYNOTE-590 includes a diverse global population.
These data can be applied to patients worldwide, and a greater survival benefit (36% reduction in the risk of death) was observed in Asian patients
.

Esophageal cancer has always been the main malignant tumor threatening the health of Chinese residents, and it is the fifth most common malignant tumor
.

The latest data released by the World Health Organization show that in 2020, there will be about 320,000 new cases of esophageal cancer in China, and 300,000 deaths, both accounting for more than half of the global incidence
.

Symptoms of early esophageal cancer are generally not obvious, often manifested as recurring foreign body sensation or choking sensation when swallowing food, or pain behind the breastbone
.

Once the above symptoms continue to appear or there is obvious choking or difficulty in swallowing food, it indicates that the esophageal cancer is in the middle and advanced stages
.

2.
2 Latest progress of domestic new drug application 2.
3 Reference of domestic new drug development progress: 1.
https:// .
https://investors.
impelnp.
com/news-releases/news-release-details/impel-neuropharma-announces-us-fda-approval-trudhesatm3.
https:// /newsroom/company_news_2021-09-06.
html