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Article source: Medical Rubik's Cube Info
According to the Prescription Drug Payment Act (PDUFA), the FDA will make review decisions on multiple drugs within the next three months
.
Among these drugs, not only the innovative drugs submitted to the FDA for registration for the first time, but also drug supplementary applications for expanded indications
Whether the Damocles sword is hovering
Whether the Damocles sword is hoveringIn January 2021, Pfizer announced the ORAL Surveillance data of a post-marketing safety study of tofacitinib.
The results showed that compared with TNF inhibitors, the incidence of major adverse cardiovascular events of tofacitinb was (3.
37% vs 2.
55) %) and the incidence of malignant tumors (4.
19% vs 2.
89%) did not reach the pre-determined primary endpoint of non-inferiority
.
In one fell swoop, the safety "Damocles Sword" hangs above all JAK inhibitors
Although other companies have always emphasized that no serious adverse events or serious infections, no thrombosis or pulmonary embolism, and malignant tumors have been observed; however, they have still failed to prevent the FDA from pressing the pause button
.
Supplemental applications for new indications (sNDA) for JAK inhibitors such as upatinib, baritinib, abuxitinib, and rocotinib have all been postponed by the FDA without exception, requesting further safety data
Starting from the end of June, these Jak inhibitors that have been postponed by the FDA will also expire again.
The FDA will take off the "Damocles Sword" or let it remain high, becoming a test that every JAK drug must accept.
It will eventually attract attention
.
Milestone drugs usher in another breakthrough
Milestone drugs usher in another breakthroughDifferent from JAKi's supplementary new drug application, the FDA will also make review decisions on a number of innovative drugs that have been submitted for marketing applications for the first time in the next three months, including Teplizumab, which is expected to become the first type 1 diabetes (T1D) antibody therapy.
In the past 10 years, the new drug Anifrolumab for the treatment of systemic lupus erythematosus (SLE) and the drugs for progressive familial intrahepatic cholestasis that have not yet been approved for new drugs
.
1.
Teplizumab
Teplizumab is a humanized, non-Fc receptor binding monoclonal antibody (mAb) that targets the CD3 epsilon chain expressed on mature T lymphocytes
.
Through the influence on regulatory T cells, the activity of autoreactive T cells that mediate the destruction of pancreatic β cells in patients with T1D can be attenuated
Provention Bio
Teplizumab was originally developed by MacroGenics and Eli Lilly, but was abandoned after a failed phase III trial in newly diagnosed diabetic patients 10 years ago
.
Provention Bio acquired Teplizumab rights in 2018 and launched a new late-stage development plan
The long-term follow-up results of the pivotal phase II (TN-10) trial showed that Teplizumab treatment delayed the progression to T1D by approximately 3 years (5 years vs.
2 years)
.
Teplizumab has also received breakthrough therapy designation from the FDA and PRIME designation from the European Medicines Agency
Provention Bio
However, at the FDA advisory panel meeting in May, experts expressed concern about safety and data from key trials and T1D patients
.
The FDA also expressed concern about APIs, because the drugs used in the TN-10 study are from Eli Lilly, and Provention Bio plans to replace it with AGC Biologics, and it needs to provide additional pharmacokinetic characteristics data for the APIs
2.
Anifrolumab
Anifrolumab (MEDI-546) is a fully human monoclonal antibody against type I interferon receptor subunit 1 (IFNAR-1) jointly developed by MedImmune (AstraZeneca) and Medarex (Bristol-Myers Squibb).
In systemic lupus erythematosus (SLE)
.
The pharmacological mechanism of Anifrolumab is different from previous antibodies against type I interferons (such as rolizumab, sifalimumab) and can block all type I interferons including IFN-α, IFN-β and IFN-ω Receptor subunit
In a phase III trial (TULIP-1), Anifrolumab failed to meet the primary clinical endpoint when evaluating the treatment of systemic lupus erythematosus based on SLE responder index 4 (SRI4)
.
In the TULIP-2 trial, the British Isles Lupus Assessment Group (BILAG) based on the Comprehensive Lupus Assessment (BICLA), anifrolumab treatment reached the primary endpoint, and the trial results showed a clinically significant reduction in disease activity, which was statistically significant
.
BICLA can record partial improvement and complete improvement at the same time, SRI can only record complete improvement and not partial improvement
.
N Engl J Med
Anifrolumab's BLA was submitted to the FDA in November 2020, and the PDUFA date is July 5, 2021
.
If approved, anifrolumab will become the second approved SLE treatment drug after the FDA approved the first BLyS-specific antibody belevumab in 2011
.
Reference source:
1.
Upcomingmarket catalysts in Q3 2021, DOI: 10.
1038/d41573-021-00108-5
2.
Medical Rubik's Cube Database
3.
The official website of each company
