In January 2022, the FDA approved two innovative drugs for insomnia and atopic dermatitis respectively

FDA approves two innovative drugs in 2022: daridorexant and abrocitinib FDA approves first innovative drug in 2022: daridorexant On January 10, 2022, Idorsia announced that the U.
S.
FDA has approved Quviviq (daridorexant) for the treatment of adult patients with insomnia
.

Insomnia is a severe sleep disorder characterized by difficulty initiating and/or maintaining sleep
.

Quviviq is a dual orexin receptor antagonist
.

Unlike normal brain-sedating treatments, it inhibits hyperactive insomnia by blocking the binding of the wake-promoting neuropeptide orexin
.

This approval is based on positive results from a Phase 3 clinical program
.

The program is divided into two pivotal trials involving a total of 1,854 adults with insomnia who were randomized to receive different doses of Quviviq or a once-daily placebo
.

The primary efficacy endpoints of both trials were the change in time required to enter sustained sleep (LPS) and wake after sleep onset (WASO) from baseline to months 1 and 3
.

LPS is an indicator of sleep onset and WASO is an indicator of sleep maintenance
.

A secondary endpoint of the trial was patient-reported total sleep time (sTST)
.

Orexin stimulates multiple wake-promoting signaling pathways (Image source: Reference [2]) The results of this phase 3 clinical program showed that Quviviq at a dose of 50 mg significantly improved objective measures of sleep onset and sleep maintenance in patients compared with placebo , and total patient-reported sleep time
.

Quviviq also significantly reduced daytime sleepiness in patients at the 50 mg dose level
.

In terms of safety, the most common adverse reactions were headache, drowsiness or fatigue
.

Dr.
Martine Clozel, Chief Scientific Officer of Idorsia, said: "After more than 20 years of research and a progressive understanding of the role of orexin in sleep-wake balance and the potential for orexin receptor antagonism, we have designed daridorexant to help address insomnia.
Multiple problems faced by patients
.

The properties of Daridorexant include potent inhibition of two orexin receptors, rapid absorption, which aids in falling asleep, and favorable pharmacokinetic profile
.

About 80% of the drug is eliminated after nighttime sleep On January 15, 2022, Pfizer announced that the US FDA approved its JAK1 inhibitor Cibinqo (abrocitinib) for the treatment
of
Adult patients with relapsing moderate-to-severe atopic dermatitis - who should not be treated with existing systemic therapies or whose condition is not controlled by these therapies
.

As a once-daily oral therapy for atopic dermatitis, Cibinqo is expected to bring new changes to the treatment of this disease
.

It is also the second new drug approved by the FDA in 2022
.

Cibinqo is an oral small molecule drug that selectively inhibits JAK1, thereby modulating multiple cytokines involved in specific dermatitis pathology, such as IL-4, IL-13, IL-22 and TSLP
.

Previously, it has obtained marketing approvals in the EU, UK, Japan, South Korea and other countries and regions
.

FDA approval is based on the results of 5 large-scale clinical trial programs, 3 of which are randomized, placebo-controlled Phase 3 clinical trials to evaluate its safety and efficacy; in addition, 2 trials are used to evaluate the drug safety
.

Taken together, the trials enrolled more than 1,600 patients
.

In the trial, Cibinqo demonstrated a sustained safety profile, with significant improvements in skin cleanliness, disease severity, disease severity, and rapid pruritus relief after two weeks of treatment
.

In two clinical trials of Cibinqo as monotherapy, a greater proportion of patients in the treatment group experienced improvement in pruritus at 12 weeks than in the placebo control group
.

The most common adverse reactions to the drug include nasopharyngitis, nausea, and headache
.

In addition, it also has some potentially serious safety risks of JAK inhibitors, including serious infections, increased mortality in certain patient populations, malignancies, major adverse cardiovascular events, and thrombosis (see reference [3] for details)
.

Abrocitinib molecular formula [4] The FDA today approved 100 mg and 200 mg doses of Cibinqo, the latter being recommended for patients who do not respond significantly to the 100 mg dose
.

In addition, the FDA has approved a 50 mg dose of Cibinqo for the treatment of patients with moderate-to-severe atopic dermatitis who have moderate renal failure, are receiving CYP2C19 inhibitors, or are known or suspected to be poorly metabolized by CYP2C19.

.

"Many patients with chronic inflammatory skin diseases, such as moderate-to-severe atopic dermatitis, experience symptoms that cannot be controlled with current therapies, and that's what these patients face
.

Today's approval of Cibinqo will bring It brings important new oral treatment options that may help these patients who are still suffering from the disease," commented Professor Jonathan Silverberg, Department of Dermatology, George Washington University, "In multiple large-scale clinical trials, Cibinqo It has strong efficacy in skin, improvement of pruritus, and control of the extent and severity of eczema, and its benefit-to-safety ratio supports its use in FDA-approved patient populations
.

Reference Source: [1] Idorsia receives US FDA approval of Quviviq (daridorexant) 25 and 50 mg for the treatment of adults with insomnia.
Retrieved January 10, 2022, from https:// details?newsId=2665386 [2] Idorsia Company Presentation.
Retrieved April 19, 2020, from https:// [3] US FDA Approves Pfizer's CIBINQO® (abrocitinib) for Adults with Moderate-to-Severe Atopic Dermatitis, Retrieved January 14, 2022, from https:// [4] Pfizer's Cibinqo snags FDA approval to challenge Sanofi and Regeneron's Dupixent in eczema, Retrieved January 14, 2022, from https:// Source | Network Sorting |