January 28, 2023

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Many drugs will face the important review decision by FDA in January 2022


Many drugs will face the important review decision by FDA in January 2022,  Roche, AstraZeneca…..

In 2021, the US FDA approved a total of 50 innovative drugs, and in 2020 there will be 53. In 2018, the number of innovative drugs approved was the largest, reaching 59.

In the past 10 years, the FDA has approved an average of 43 innovative drugs each year.


Entering January 20221, many drugs will usher in an important review decision by the FDA. The following is a brief summary of these drugs.



1. OPKO Health/Pfizer somatrogon

Somatrogon is a new molecular entity that contains the natural sequence of human growth hormone and the C-terminal polypeptide (CTP) of the human chorionic hCGβ chain. CTP prolongs the half-life of growth hormone.

Somatrogon has been awarded the title of “Orphan Drug” in the United States and the European Union for the treatment of children and adults with growth hormone deficiency.


A randomized, open-label, phase III clinical controlled trial of positive drugs conducted by Somatrogon in more than 20 countries enrolled and treated 224 children with GHD who had not previously received treatment.

In the study, these patients were randomly assigned to two treatment groups at a ratio of 1:1: somatrogon treatment group (0.66mg/kg, once a week), Genotropin (somatropin) treatment group (0.034mg/kg, daily dosing) once). The primary end point of the trial is the height velocity during 12 months of treatment.

Secondary endpoints include changes in height standard deviation at 6 months and 12 months, safety, and pharmacodynamic indicators.

Children who complete the study have the opportunity to participate in a global, open-label, multi-center, long-term extension study, in which patients can continue to receive or switch to somatrogon treatment.

Approximately 95% of patients have been transferred to the open-label extension study and have received somatrogon treatment.


The results showed that the study reached the primary endpoint of non-inferiority: the average least squares of the somatrogon group (10.12 cm/year) was higher than that of the Genotropin group (9.78 cm/year) at 12 months of treatment; the height growth rate (cm/year) The treatment difference (somatrogon-Genotropin) was 0.33 (two-sided 95% confidence interval: -0.39, 1.05).

Compared with the Genotropin group, the somatrogon group had higher changes in height standard deviation scores (key secondary endpoints) at 6 months and 12 months.

In addition, at 6 months, compared with the Genotropin group, the somatrogon group had a higher change in height growth rate, another key secondary endpoint.

In a clinical setting, these commonly used growth measurement methods are used to measure the potential that subjects may experience to catch up with age- and gender-matched peers’ height growth.


In this study, somatrogon was generally well tolerated, and the type, number and severity of adverse events observed between treatment groups were comparable to the once-daily growth hormone Genotropin.



2. AstraZeneca Lynparza

Lynparza is a first-of-its-kind oral poly-ADP ribose polymerase (PARP) inhibitor that can take advantage of defects in the tumor DNA damage repair (DDR) pathway to preferentially kill cancer cells.

This mode of action gives Lynparza treatment for DNA damage repair defects Potential for a wide range of tumor types (such as BRCA1 and/or BRCA2 mutations).


In July 2017, AstraZeneca and Merck reached a global strategic cooperation in oncology to jointly develop and commercialize Lynparza and another MEK inhibitor selumetinib to treat a wide range of tumors, including breast, prostate, and pancreatic cancer.


Lynparza is the world’s first PARP inhibitor and was first approved by the US FDA in December 2014. So far, Lynparza has been approved for 7 treatment indications:

(1) first-line maintenance treatment for adults with BRCAm advanced ovarian cancer;

(2) combined bevacizumab first-line maintenance therapy for adults with HRD-positive advanced ovarian cancer;

(3) maintenance therapy Adult patients with recurrent ovarian cancer;

(4) Adult patients with advanced gBRCAm ovarian cancer;

(5) Treatment of gBRCAm, HER2-negative (HER2-) adult patients with metastatic breast cancer;

(6) First-line maintenance therapy for adults with gBRCAm metastatic pancreatic cancer;

(7) Treatment of patients with metastatic castration-resistant prostate cancer (mCRPC) who carry specific gene mutations.



3. Roche faricimab

Faricimab is a bispecific antibody designed for the eye. It can treat a variety of retinal diseases by blocking two pathways: Angiopoietin 2 (Ang-2) and Vascular Endothelial Growth Factor A (VEGF-A). Ang-2 and VEGF-A destabilize blood vessels, leading to the formation of new leaky blood vessels, increasing inflammation, and leading to decreased vision.


Roche’s BLA application for faricimab is based on the positive results of four phase 3 clinical trials, one for patients with wet AMD and one for patients with DME.

All trials met their primary endpoint, showing that faricimab administered every 4 months achieved non-inferiority criteria for visual benefit compared to the current standard treatment administered every two months.


In addition, about half of patients with wet AMD or DME who are suitable for prolonging the interval between faricimab dosing only need to receive the dosing every 4 months during the first year of treatment.

The press release pointed out that faricimab is the first ocular injection drug to achieve such a long durability in a phase 3 clinical trial of wet AMD and DME.

In terms of safety, faricimab was generally well tolerated in all 4 trials, and no new/unexpected safety signals were found.




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Many drugs will face the important review decision by FDA in January 2022

(source:internet, reference only)

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