In the first half of this year, a large number of new drug applications by pharmaceutical companies have been approved by the FDA. According to the summary of Evaluate Pharma, 5 blockbusters that may be potentially approved by the FDA or have just been approved in the remaining months of 2021. According to Evaluate's estimates, by 2026, the total sales of these drugs can reach 8.6 billion US dollars.

1. Efgartigimod

One of the most likely to receive FDA approval is from Argenx myasthenia gravis (gMG) therapy Efgartigimod, which is an autoimmune disease that causes loss of muscle function. The regulatory decision date for the drug is December 17. According to estimates by SVB Leerink, by 2030, the market value of the US market in this field may be as high as $25 billion.

If finally approved, efgartigimod will be the first anti-neonatal Fc receptor (FcRn) drug approved by the FDA. Evaluate predicts that Efgartigimod's sales will reach US$3 billion by 2026.

Efgartigimod has the ability to block FcRn (a protective receptor for immunoglobulin IgG) and plays a central role in preventing the degradation of IgG antibodies. This mechanism is also believed to reduce the pathogenicity associated with several autoimmune diseases. Sex IgG antibody. Earlier, Efgartigimod released positive data from a late-stage test of muscle weakness, which confirmed that the drug can relieve symptoms better than placebo after 26 weeks of treatment. According to the company, among patients who took Efgartigimod and tested positive for acetylcholine receptor antibodies (an MG indicator), nearly 68% of patients responded to the drug, compared with 29.7% in the placebo group.

In addition to the US market, Argenx is also trying to promote the development potential of Efgartigimod in five other indications, and is actively seeking approval for the drug in Europe and Japan. At the end of August, the drug's marketing application (MAA) submitted to the European Medicines Agency (EMA) was accepted. If approved by the EMA, Efgartigimod will also become the first and only FcRn antagonist to be marketed in Europe.

2. Bimekizumab

If the psoriasis monoclonal antibody bimekizumab is approved by the FDA before the October 15 decision date, UCB will face fierce competition. If it is finally approved, there is evidence that the efficacy of the drug can beat related products from Johnson & Johnson and Novartis. Evaluate estimates that by 2026, bimekizumab sales are expected to reach US$2 billion. In September of this year, the European Commission approved the marketing of bimekizumab for the treatment of patients with moderate to severe plaque psoriasis who are suitable for systemic therapy. The drug has also become the EU’s first IL-17A approved for the treatment of psoriasis. /IL-17F inhibitor.

3. Faricimab

During the pandemic, Bayer and Regeneron not only managed to overcome the difficulties with their best-selling ophthalmic drug Eylea, they even managed to expand the drug's market share in the process. Now, as the FDA is weighing the application decision of Faricimab for the treatment of wet age-related macular degeneration (AMD) and diabetic macular edema (DME), Roche is hoping to re-adjust the distribution of its existing market share through Faricimab. The approval is expected to be completed before the end of the year.

Faricimab is the first bispecific antibody specifically designed for intravitreal injection, which can simultaneously strongly and specifically bind to and neutralize Ang-2 (angiogenin-2) and VEGF-A (vascular endothelial growth factor A). Ang-2 and VEGF-A can destabilize blood vessels, cause new leaky blood vessels to form and increase inflammation, which can lead to decreased vision. According to previous trials, Roche has proven that Faricimab can at least be as effective as Eylea, the best-selling drug in the world, which ranked sixth in the clinical world last year. Roche found in four phase 3 trials that, despite the longer dosing interval of patients, the bispecific antibody Faricimab is not less effective than Eylea against VEGF and Ang2.

Throughout the trial, after receiving Faricimab treatment, about half of the patients were able to maintain it for four months, while Eylea needed to be administered once every two months. Since these drugs need to be injected through the patient's eyes, Roche Faricimab is more convenient for patients. However, this alone may not be enough to catch up with the huge lead of Regeneration Yuan. It is estimated that Roche Faricimab's sales in 2026 can reach 1.1 billion US dollars, which is far lower than Eylea's current sales.

4. Abrocitinib

Previously, due to Pfizer’s JAK inhibitor Xeljanz, patients have experienced a series of safety incidents, which caused strong control of all JAK inhibitors by federal regulatory agencies. At present, as the FDA's months-long safety investigation of Pfizer Xeljanz has come to an end, other JAK inhibitors seem to be re-approved by the FDA at the end of the year, including another highly anticipated atopic dermatitis drug, abrocitinib. In September, the British Drugs and Medical Products Regulatory Agency (MHRA) granted marketing authorization for abrocitinib for the treatment of moderate to severe atopic dermatitis in adults and adolescents aged 12 years and over who are suitable for systemic therapy. The recommended doses are 100mg and 200mg. It is also the first marketing authorization for this therapy in the world.

Previously, regulatory agencies rejected applications for other JAK inhibitors for safety reasons, including Gilead’s filgotinib for rheumatoid arthritis. So far, neither Pfizer nor the FDA has stated whether the previous investigation would prevent abrocitinib from obtaining regulatory approval. In late August, Pfizer stated that in the second and fourth weeks of the oral drug abrocitinib, it defeated Sanofi and Dupixent in terms of clearing the patient’s itching and eczema symptoms, but the key details of the drug’s safety are still unknown. .

5. Skytrofa

Another medicine comes from Ascendis Pharma's weekly long-acting long-acting hormone injection lonapegsomatropin-tcgd (trade name Skytrofa). The drug was approved by the FDA not long ago, and the drug is expected to have sales of 1.5 billion U.S. dollars by 2026.

The approval of Skytrofa provides an important new option for weekly treatment for children with growth hormone deficiency and their families. Approved along with Skytrofa also includes the new Skytrofa® auto-injector and pill box, which can be stored at room temperature for up to 6 months after being removed from the refrigerator for the first time. If the injection is changed from once a day to once a week, the number of injection days per year for children can be reduced by 86%.