Sales of 5 drugs may reach US$8.6 billion in the next five years!

CompilationFan Dongdong

In the first half of this year, a large number of new drug applications from pharmaceutical companies have been approved by the FDA.

1.

If finally approved, efgartigimod will be the first anti-neonatal Fc receptor (FcRn) drug approved by the FDA

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.

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

2.

In two previous independent late-stage studies, UCB's bimekizumab successfully defeated Johnson & Johnson's blockbuster Stelara and Novartis Cosentyx in removing the skin of patients with moderate to severe plaque psoriasis

Based on the above test results, analysts estimate that if bimekizumab can produce the same therapeutic effect as Cosentyx, then the drug's sales prospects may increase further

3.

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)

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

4.

However, analysts also pointed out that in view of the previous long-term successive deaths and carcinogenic cases, the entire JAK inhibitor has had an adverse effect, so whether abrocitinib can obtain regulatory approval in the future is still pending
.
JAK inhibitors previously regulated by the FDA include Pfizer Xeljanz, AbbVie Rinvoq, and Eli Lilly Olumiant
.
Therefore, abrocitinib may also face the same dilemma when applying for regulatory access
.
Evaluate estimates that sales of abrocitinib may reach $1 billion by 2026, which is less than one-third of Pfizer's expected peak potential
.

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 drug's FDA approval was mainly based on the results of the phase 3 heiGHt trial
.
The 52-week trial is a global, randomized, open-label, controlled trial.
Among 161 children with growth hormone deficiency who have not received previous treatment, the study compared Skytrofa treatment once a week and growth hormone once a day.
The effect of Genotropin treatment
.
After 52 weeks of treatment, the annual height growth rates of the once-a-week Skytrofa treatment group and once-a-day growth hormone treatment group were 11.
2 cm/year and 10.
3 cm/year, respectively, with a difference of 0.
9 cm/year
.
At the same time, the safety of the two treatments is similar
.

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 the child can be reduced by 86%
.

Reference source: From Pfizer to Argenx: A look at potential blockbusters awaiting FDA decisions this year