As recently as 2020, the pace of FDA approval reviews does not appear to have slowed, even though the COVID-19 pandemic has had a significant impact on drug development for companies.
, the FDA approved 53 new drugs last year, close to the record set in 2018.
of course, the approval data does not include certain biopharmace technology products, nor does it include an emergency use authorization for two new crown vaccines released by the FDA last month.
2021 is certainly a year to look forward to.
While the new coronavirus vaccine will remain a major focus of the FDA's work, it is worth noting that the FDA will soon make one of the most important decisions in its recent history: whether to approve the controversial Alzheimer's treatment drug Aducanumab.
and is expected to make a decision by the end of March on heart failure drugs, new dousing muscular dystrophy drugs and cancer cell therapy drugs.
here are five drugs the FDA will decide whether to approve in the first quarter of 2021: 01 Mercado and Bayer's chronic heart failure drug Vericiguat Although there are already multiple drugs on the market, the prognosis for heart failure patients remains poor.
estimates that the medium survival period after hospitalization for heart failure patients is just over two years.
and few new drugs have improved on existing treatment options.
exception to the U.S. drug was Novaral's chronic heart failure drug Entersto, approved in July 2015.
is the first innovative drug to work on the heart's neuroendocrine system in a variety of ways, a major breakthrough in heart failure treatment over the past two decades.
Vericiguat was the first "first-in-class" soluble bird nucleotide cyclase (sGC) astracite developed for the treatment of patients with worsening chronic heart failure, developed and commercially promoted jointly by Mercadon and Bayer.
trial showed that Vericiguat reduced the risk of re-hospitalization or death by 10 percent after routine treatment of newly hospitalized patients.
, the drug had no effect on cardiovascular death when the data were examined carefully.
FDA is expected to make a decision on January 20.
note that Vericiguat has filed for listing in the European Union, Japan, the United States and China, according to previous Bayer announcements.
also means that the product is expected to be approved simultaneously in many countries and regions.
02 Sarepta's new drug for the treatment of Duchia muscular dystrophy, Sarepta's new drug, Casimersen, filed a new drug with the FDA in June 2020.
as Sarepta's third exon skip drug to use its proprietary PMO RNA platform, Casimersen is specifically designed to treat DMD patients who skip exon 45, which accounts for about 8 percent of all DMD patients.
, the FDA had approved Sarepta's first two drugs, Exondys 51 and Vyondys 53.
in clinical studies, Casimersen stimulated the production of a key muscle building protein called muscular dystrophy protein, which reached about 2 percent of normal levels after treatment and less than 1 percent of normal levels at baseline.
fda is expected to make a decision on Casimersen's approval on February 25.
Regeneron's new drug for advanced lung cancer immunotherapy, Libtayo, is a late-stage immunotherapy star, and Regeneron already has several competitive drugs, among which the new drug Libtayo for advanced lung cancer immunotherapy has won the first batch.
, sales of the product have so far been low.
total sales for the nine months to 2020 are estimated at about $251 million.
, however, sales are likely to increase significantly as two new approval decisions are expected this quarter, most notably first-line lung cancer, one of the most competitive areas in the sector.
immunotherapy has changed the way many lung cancer patients are treated.
combination of Keytruda and chemotherapy in Mercedon has become the standard treatment for most people newly diagnosed with advanced non-small cell lung cancer, the most common form of the disease.
Regeneron hopes to make a difference.
fda is expected to make Libtayo's approval decision on February 28.
2021 FDA will again face a decision on whether to approve Aducanumab, a new drug for Alzheimer's disease.
Aducanumab is a monoclonal antibody that targets β amyloid proteins, which selectively binds to amyloid deposits in the patient's brain, reducing the build-up of β amyloid proteins and thus slowing disease progression.
, despite its mixed and controversial trial data, a group of outside consultants voted decisively on the drug's risk-taking status after working with the company to review its approval application.
now, if the FDA follows the advisory board's recommendations, it could disappoint patients, families and advocates seeking new Alzheimer's treatments.
if regulators ignore the commission, they risk damaging their reputation as independent arbiters of safety and effectiveness.
the agency's choice would have huge consequences, especially for the chain reaction to Alzheimer's research.
FDA is expected to make a decision on Whether to approve Aducanumab on March 7.
05 BMS and Bluebird's multiple myeloma therapy drug ide-cel ide-cel, or idecabtagene vicleucel, is a B-cell mature antigen (BCMA)-oriented chiline antigen recipient (CAR) T-cell therapy for adult patients who have previously received at least three therapies, including immunomodulants, protease inhibitors, and anti-CD38 antibodies.
BMS acquired the rights to the product two years ago in its $74 billion acquisition of New Base.
in the United States and the European Union, ide-cel was awarded breakthrough drug eligibility (BTD) and priority drug eligibility (PRIME), respectively.
approved, it would be the first cancer cell therapy to be approved for multiple myeloma.
clinical trials have shown that ide-cel is an effective treatment that eliminates or reduces cancer in more than three-quarters of the study participants, although ide-cel can cause serious side effects in a small number of people.
FDA is expected to make a decision on whether to approve it on March 27, 2021.