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Cocktail therapy for Ebola virus infection, APKS-3831 for schizophrenia and biplex disorder, is expected to become the fourth CAR-T treatment to be approved for sale... What are the highlights of the new drug review that deserve attention? In addition to doing its best to deal with the COVID-19 pandemic, the FDA's normal work is on a orderly footing.
In the fourth quarter of this year, attention was focused on drugs under review, including a cell therapy for lymphoma, a compound drug for schizophrenia, a new anemia drug, and an antibody for the Ebola virus.
for Ebola virus infection EB3, developed by reGEN-EB3Regeneron, a cocktail therapy used to treat Ebola virus infection, will be announced next month.
to respond to the 2014 Outbreak of Ebola in West Africa, Regeneron relies on antibody drug technology to fight Ebola virus infection.
company launched REGN-EB3 in just a few months.
this is a cocktail therapy made up of 3 antibodies.
the 2014 Ebola outbreak, it will have to wait for the outbreak to re-emerge to prove the value of the treatment.
last year, a new Ebola outbreak broke out in the Democratic Republic of the Congo, and REGN-EB3 tested positive for multiple drugs, outperforming the controlled drug in terms of survivability after 28 days.
whether reGN-EB3 will be approved will be announced on October 25 this year.
ALKS-3831, which is used to treat schizophrenia and type I biphalphic disorders, is key to this transformational strategy for Alkermes, which is transitioning from a specialized pharmaceutical delivery company to a pharmaceutical company.
APKS-3831, a compound drug for the antipsychotic drugs Zyprexa and Samidorphan, is expected to help reduce the weight loss associated with Zyprexa.
ALKS-3831, a compound drug for the antipsychotic drugs Zyprexa and Samidorphan (Photo: PubChem) However, Alkermes has not yet clearly demonstrated this theory.
in a four-week study, patients treated with Zyprexa or APKS-3831 gained weight at a similar rate.
in a second longer trial, the drug was superior to Zyprexa in terms of weight gain.
based on clinical trial results, Alkermes sought FDA approval for drugs to treat schizophrenia and biplex disorder.
Alkermes will submit a set of mixed data to the FDA advisory board on October 9.
FDA has until November 15 to make a decision.
Liso-cel, which is used to treat non-Hodgkin's lymphoma, filed an application with the FDA in December 2019 and was eligible for a priority review, with the FDA scheduled to make a decision on whether to approve it by June this year.
in May, the FDA delayed a decision.
, whether liso-cel will be approved will be announced on November 16 this year.
if Liso-cel can get FDA approval, it will be the fourth CAR-T treatment to go public, after Kymriah, Yescarta and Tecartus.
people with anaemia and kidney damage have been treated with biological injections for decades, according to roxadustat, which treats chronic kidney disease.
on December 20th this year, if FibroGen's roxadustat is approved, it could upend the market.
Roxadustat stick structure (Photo: PubChem) Roxadustat is one of the most advanced of these emerging drugs by "spoofing" the body into thinking it is in a low oxygen state to stimulate red blood cell production, thereby increasing hemoglobin levels in anemia patients.
results in patients with chronic kidney disease have shown that these drugs are comparable to biological products.
References: . . . . . . . . . . . . . . . . . . . . . . Emergency Use Authorization for Vaccines to Prevent COVID-19 Guidance for Industry. October, 2020. Retrieved Oct 7, 2020 from Michael Mezher. FDA issues COVID-19 vaccine EUA guidance after clash with White House. Oct 6, 2020. Retrieved Oct 7, 2020 from . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .