Pfizer's third-generation APK inhibitors are eligible for FDA priority review; AstraZenecom's new crown vaccine is approved for emergency supply in the UK

Myovant Sciences and Pfizer have jointly announced an agreement to develop and promote oral gondiogen-releasing hormone (GnRH) contagion agent relugolix for oncology and women's health diseases in the United States and Canada.
will also have exclusive options to promote the use of relugolix in oncology in other parts of the world outside the United States and Canada, except in some Asian countries.
Relugolix is an oral GnRH-like antagonist that binds and blocks GnRH-in-the-pituitary prelobes, reducing the release of progesterone-producing hormones (LH) and follicle stimulators (FSH), thereby reducing estrogen levels produced by the female ovaries and male testosterone production.
, it was approved by the U.S. FDA to treat male patients with advanced prostate cancer with androgen sensitivity.
is the first oral hormone therapy to treat such patients.
same time, Myovant has submitted a new drug application to the FDA to treat uterine fibroids using relugolix compound tablets (relugolix 40 mg, estradiol 1.0 mg and acetone 0.5 mg).
the compound tablet also reached its main endpoint in Phase 3 clinical trials for endometriosis, which can alleviate the symptoms of pain in 75% of patients.
a diagram of the mechanism of the role of Relugolix (Photo: Myovant Sciences website) Under the agreement, Myovant and Pfizer will jointly develop and commercialize relugolix for the treatment of advanced prostate cancer.
FDA approval, the company will jointly develop and commercialize relugolix compound tablets in the United States and Canada for the treatment of diseases in women's health.
Myovant will continue to oversee interactions and drug supply, and will continue to lead the clinical development of relugolix compound tablets.
Myovant received up to $4.2 billion in payments, including $650 million in upfront payments.
breakthrough itching therapy has filed a new drug application seeking priority review of Cara Therapeutics, which recently announced that it has submitted a new drug application (NDA) for Korsuva injections to the FDA to treat severe itching in patients with hemodialysis.
Korsuva is a small molecular inhibitor that selectively targets exosome opioids (KORs).
it has been recognized as a breakthrough therapy awarded by the FDA.
Cara has requested a priority review of the NDA, which, if approved, could be reduced to six months.
associated with chronic kidney disease (CKD-aP) is a stubborn, systemic itching disorder that occurs mostly in CKD patients receiving hemodialysis and peritina dialysis.
stage III-V CKD patients who do not receive dialysis treatment also have itching.
comprehensive longitudinal multi-country study, it is estimated that about 60%-70% of dialysis patients will develop itching, of which 30% to 40% are moderate to severe itching.
itch treatments, such as antihistamines and corticosteroids, are currently used for these patients, but they do not provide consistent and adequate relief.
severe chronic itching can have a direct impact on the quality of life of patients, such as poor sleep quality, and may even lead to depression.
Korsuva is a highly selective exosome opioid-subjected exciterant.
it has strong analgesic, anti-inflammatory and anti-itching effects in both humans and animals.
Because Korsuva performs poorly in penetrating the blood-brain barrier, it has little or no central nervous system (CNS)-mediated side effects such as nausea, vomiting, sedation, respiratory suppression, abuse, addiction, or euphoria.
Difelikefalin Molecular Structure (Photo: Edgar 181), Public domain, via Wikimedia Commons, an NDA submission supported by positive data from two key Phase 3 clinical trials, including the KALM-1 trial in the United States and the global KALM-2 trial, as well as support data from 32 other clinical studies.
In the randomized double-blind, placebo-containing controlled group of phase 3 clinical trials KALM-2, 54 percent of patients in the treatment group had a 24-hour itching intensity numeric scale (WI-NRS) score reduced by 3 points or more during the 12th week of treatment, compared with 42 percent of patients in the placebo group who reached this level, reaching the primary endpoint of the trial.
addition, 41 percent of patients in the treatment group had WI-NRS scores that improved by 4 points or more compared to the baseline, and only 28 percent of patients in the placebo group reached that level, reaching a critical secondary endpoint of the trial.
The first-line treatment of non-small cell lung cancer, Pfizer's third-generation ALC inhibitor is eligible for FDA priority review Pfizer recently announced that the FDA has accepted the company's application for a new drug (sNDA) for the first-line treatment of ALC positive metastasis non-small cell lung cancer (NSCLC) patients.
FDA also grants this sNDA priority review qualification and is reviewing it using the Real-Time Oncology Review (RTOR) pilot project, with a response expected by April 2021.
lung cancer is one of the leading causes of cancer-related deaths worldwide.
NSCLC accounts for about 80-85% of lung cancer, and ALK-positive tumors occur in about 3-5% of NSCLC cases.
Lorbrena is a tyrosine kinase inhibitor (TKI) that is highly active in preclinical lung cancer models that carry APK rear-rowing.
Lorbrena specializes in inhibiting APK gene mutations that are resistant to other APK inhibitors and can penetrate the blood-brain barrier to treat brain metastasis.
brain metastasis in up to 40% of APK-positive lung cancer patients.
application was supported by positive results from PHASE 3 clinical trial CROWN.
interim analysis published in the New England Journal of Medicine in November 2020 showed that Lorratinib reduced the risk of disease progress or death by 72% compared to the current first-line standard treatment crizotinib (HR=0.28,95% CI:0.19-0.41, P.lt;0.001).
progress-free lifetime (PFS) in the 12th 19th group was 9.3 months, while the mid-PFS in the La Trotinie group had not yet been achieved. The progress-free survival of patients in the
-Lauratinib group (blue line) and the closinib group (red line) (Photo source: Reference 4)) also showed significant advantages in the prevention and mitigation of brain metastasis.
at 12 months, the survival rate for progression of intracranial disease in the Loracinie group was 96 per cent, compared with 60 per cent in the clotinist treatment group.
reduced the risk of intracranial disease progress or death by 93%! AstraZeneca's new crown vaccine was approved for emergency supply in the UK on 30 December 2020, when AstraZeneca announced that the UK Medicines and Health Products Authority (MHRA) had authorised the emergency supply of its new crown vaccine, AZD1222, to individuals aged 18 or over.
MHRA's authorization recommends that the vaccination be given twice, at intervals of 4-12 weeks.
the program has shown in clinical trials that symptomatic COVID-19 can be safely and effectively prevented, with no hospitalizations or severe cases for more than 14 days after the second drug was given.
MHRA's decision is based on independent recommendations from its Commission on Human Medicines following a rolling review of clinical trial data for AZD1222, including an interim analysis of Phase 3 clinical studies led by Oxford University.
data were also published in The Lancet on 8 December 2020.
said it plans to supply millions of doses in the first quarter of 2021, with a total supply of up to 100 million doses in the UK.
will continue to work with regulators around the world to support their rolling review of the vaccine's emergency supply or conditional listing during the health crisis.
AstraZeneta is also seeking the vaccine to be included in the World Health Organization's emergency use list to accelerate the availability of vaccines in low- and middle-income countries to ensure widespread and equitable access to vaccines in an unprofitable manner during pandemics.
said it was working with its global partners to continue rolling capacity to produce up to 3 billion doses of the vaccine pending regulatory approval.
the vaccine can be stored, transported and treated for at least 6 months under normal refrigeration conditions (2-8 degrees C/36-46 degrees Fahrenheit) and inoculated in an existing health care environment.
AZD1222 was developed by Oxford University and its spin-off company, Vaccitech.
the end of April 2020, AstraZeneta and Oxford University in the UK jointly announced an agreement to jointly develop, mass produce and distribute the new crown virus candidate vaccine.
AZD1222 uses a replicated defective chimpanzee virus vector based on a weakened version of the common cold virus (adenovirus), which causes chimpanzee infection and contains genetic material from the SARS-CoV-2 virus prickly protein.
the vaccine, it produces surface prickly proteins, triggering the immune system to produce antibodies against the new coronavirus.
AZD1222 mid-stage analysis was based on data from 11,636 patients with COVID-19 who developed symptoms during a Phase 3 clinical trial led by Oxford University in the UK and Brazil.
As announced on 23 November 2020, the main effectiveness endpoints based on a summary analysis showed an effective rate of 70.4% (confidence interval: 54.8%-80.6%) for preventive symptomatic COVID-19 over 14 days after receiving two doses of the vaccine.
the end point of secondary efficacy in the prevention of severe diseases, there were no serious or hospitalized cases in the vaccine group.