If you think Covid-19 has delayed approval of new drugs from the U.S. Food and Drug Administration (FDA), you're wrong.
even as the outbreak spreads, the FDA seems more active than ever.
by the end of June 2020, the FDA has approved 33 new drugs, and according to this trend, approvals for new drugs in 2020 are roughly the same as in the past two years (62 new drugs approved in 2018 and 54 in 2019).
meanwhile, the European Medicines Agency (EMA), which approved 41 drugs in the first half of the year, 27 of which were new.
of the 33 new drugs approved by the FDA, the Center for Drug Review and Research (CDER) approved 25 neomolecular entities and new therapeutic biologics, almost half (12) of which were oncology drugs.
the field of oncology (10) new drugs approved by the EMA also dominates.
based on the FDA and EMA's first-half approval of the new drug's indications and market competitiveness analysis, Pharma Compass recently forecast sales of TOP10 drugs, as follows: Conditionally approved Remdesivir as this year's biggest winner Gilead Remdesivir is undoubtedly one of the most talked about drugs this year.
although some of the drug's studies are still under clinical evaluation, the FDA, the European EMA and the U.S. Ministry of Health, Labour and Japan (MHLW) all provide market access for the drug.
May 1 this year, the FDA, based on all the scientific evidence available, was the first to issue an Emergency Use Authorization (EUA), arguing that Remdesivir may be effective in treating Covid-19, and that the known and potential benefits of treating Covid-19 outweigh its risks. On June 25,
, the EMA Human Drug Commission (CHMP) issued a positive opinion recommending that the drug (European product name Veklury) be licensed for "conditional" sale.
Remdesivir was in short supply as soon as it went on the market, buying more than half a million doses in the US, which is 100 per cent of Giard's production in July and 90 per cent in August-September, leaving little inventory in the UK and Europe.
in 127 low- or middle-income countries, Gilead allowed generic drugmakers to supply the drug, further expanding its supply.
most drugs are approved in the order of the first U.S. and then the European Union, such as trikafta, the three-drug combination, which was approved by the FDA three months after the listing application was submitted for outstanding clinical data.
june this year, the EMA adopted a positive opinion from CHMP and granted the marketing rights to the combination drug Kaftrio (European product name).
, such as Novartis/Avexis's Zolgensma, Novartis Piqray, Pfizer Staquis and Daurismo, all received FDA approval in 2019.
"first" drug was approved this year, which also saw the first non-statins approved for sale in the United States in nearly 20 years.
the drug, called Nexletol (bempedoic acid), is produced by Esperion Therapeutics and is designed to help millions of patients who cannot tolerate or get satisfaction from widely used statins, such as lipocose and canbe be determined, to lower cholesterol.
the new drug will be used as an add-on to statins, reducing the amount of harmful cholesterol or low-density lipoprotein (LDL) in the liver and targeting patients at high cardiovascular risk.
, bempedoic acid was approved in conjunction with another cholesterol-lowering drug, ezetimibe.
and Trodelvy is the first FDA-approved antibody drug conjugated (ADC) drug for recurrent or refractory mTNBC, and the first ADC drug to fight glycoprotein Trop-2, offering hope to TNBC patients who are ineffective with both hormone therapy and HER2 targeted therapies such as Trastuzumab.
the drug, which binds antibodies to TROP-2 antigens expressed on most breast cancer cells, delivers the chemotherapy drug Iliticon directly to tumor cell microenvironments, and also delivers the drug to tumor cells that do not express Trop-2, thereby reducing the toxic effects of previous systemic administration.
nearly 20 drugs have not been approved In the face of the outbreak setback, some drugs have not been approved smoothly.
about 20 new drugs were rejected by the FDA in the first half of this year, including BMS and Bluebird Bio's CAR-T-idecabeagene-Vicleuel (Cel) for recurrent and refractory multiple myeloma, which the FDA considers to be required to provide further details to complete the review, but not the need for clinical or non-clinical data.
in addition, Intarcia Therapeutics' long-term implantation drug ITCA-650 was rejected again two years after being rejected, and it is understood that the implant was designed as a small osmosis pump that can slide under the skin and provided a six-month dose of glP-1 agonisante exenatide (Essenatide).
the FDA has also approved Intercept Pharmaceuticals' non-alcoholic fatty hepatitis (NASH) treatment drug, obeticholic acid, because it does not believe the benefits outweigh the potential risks.
after acquiring Ayr for $63 billion, AbbVie hopes to be one of the first drugs approved for the experimental DARPin ® therapy for newborn blood vessels (wet) age-related macular degeneration (nAMD).
However, the FDA study noted that the drug was rejected after the administration was observed to increase the rate of inflammation in the patient's eye, resulting in an adverse benefit-risk ratio.
conclude that while all eyes are on the Covid-19 pandemic, regulators are busy bringing new drugs to market.
by the middle of the year, we realized that the FDA and EMA seemed on track to set approval records this year, as the number of drugs approved by June was almost double the number approved in the same period last year.
while the number of approvals has not decreased, the Covid-19 pandemic has hindered the smooth launch of the drug, resulting in sales losses.
BMS's multiple sclerosis treatment drug, Zeposia, is currently approved in the U.S. and Europe and is one of the most anticipated drug approvals this year.
, the drug is also a core product of BMS's $74 billion acquisition of Celgene and returns for investors in both companies.
however, the listing of Zeposia will be delayed due to a global outbreak.
it remains to be seen how companies will adjust their sales and marketing strategies in a world where liquidity is likely to be limited and business transactions are significantly reduced.
References 1.New Drug Approves by FDA and FDA EMA (Mid-2020 Recap) 2.US secures world stock of key Covid-19 drug remdesivir 3.Bristol Myers Squibb and bluebird bio-provide rifon Update on Idecabagene Vicleucel (ide-cel, bb2121) SSIS FIBRO DUE TO NASH.