- BIown / — Biomin is a global biotechnology company dedicated to the development and commercialization of innovative therapies for patients with severe and life-threatening rare and ultra rare genetic diseases.
- If approved, vosoritide will be the first drug to treat achondroplasia. It can treat the root cause of the disease, represents a major medical breakthrough, and has the potential to have a meaningful impact on the lives of patients.
- Vosoritide is a kind of C-type natriuretic peptide (CNP) analogue derived from natural human peptides.
- Source: biomrin submissions marketing authorization application to European Medicine Agency for vosoritide to treat children with achondroplasia
BIown / — Biomin is a global biotechnology company dedicated to the development and commercialization of innovative therapies for patients with severe and life-threatening rare and ultra rare genetic diseases.
Its product portfolio includes seven commercial products and a variety of clinical and preclinical candidates. Recently, the company announced that it had submitted a marketing authorization application (MAA) for vosoritide (vosoride, bmn111) to the European Drug Administration (EMA). The company also plans to submit a new drug application (NDA) for vosoritide to the U.S. Food and Drug Administration in the third quarter of 2020.
Vosoritide is a once daily injection of C-type natriuretic peptide (CNP) analogue for the treatment of achondroplasia, the most common disproportionate short stature in humans. Previously, vosoritide has been awarded the orphan drug qualification (odd) for the treatment of achondroplasia.
If approved, vosoritide will be the first drug to treat achondroplasia. It can treat the root cause of the disease, represents a major medical breakthrough, and has the potential to have a meaningful impact on the lives of patients.
Achondroplasia is the most common and disproportionate form of short stature in human beings. It is characterized by slow endochondral ossification, resulting in disproportionate shortness and structural disorder of long bones, spine, face and skull base. This is caused by mutations in the fibroblast growth factor receptor 3 gene (FGFR3), which is a negative regulator of bone growth.
In addition to disproportionate short stature, patients with achondroplasia may experience severe health complications, including macropore compression, sleep apnea, bent legs, facial dysplasia, permanent lower back swing, spinal stenosis, and recurrent ear infections. Some of these complications may result in the need for invasive surgery, such as decompression of the spinal cord and extension of the bent legs. In addition, studies have shown that mortality rates are increasing for every age group.
Vosoritide is a kind of C-type natriuretic peptide (CNP) analogue derived from natural human peptides.
It is an effective stimulant for endochondral ossification. Natural human peptide is a positive regulator of bone growth. Vosoritide binds to specific receptors and activates intracellular signals that inhibit the overactive FGFR3 pathway.
The regulatory application of vosoritide is based on the results of a global randomized, double-blind, placebo-controlled phase III study published in December 2019, and further obtains the long-term safety and efficacy data and extensive natural disease history data of the ongoing phase II and phase III extended studies.
The global phase III study included 121 children with achondroplasia, aged 5-14 years, whose growth plates were still open. The efficacy and safety of vosoritide and placebo were evaluated. These patients completed at least 6 months of baseline study to determine their respective baseline growth rates before entering phase III study. In the phase III study, patients were randomly assigned to receive vosoritide (15ug / kg / day) or placebo for 52 weeks. The primary end point was the change in growth rate from baseline in children treated with vosoritide over a one-year period compared with placebo.
The results showed that the main endpoint of the study was achieved: after one year of treatment, the change in growth rate of vosoritide treatment relative to baseline was 1.6 cm / year (P < 0.0001). The results are consistent with the results of a large number of patients studied. In the study, vosoritide was generally well tolerated without clinically significant blood pressure drop.
The results of an open label, dose discovery phase II study published in November 2019 showed that cohort 3 (n = 10) patients treated with 15 μ g / kg / day vosoritide increased their cumulative average height by 9.0 cm over a period of 54 months, compared with age and gender matched children in a new natural history achondroplasia data set (n = 619) The difference was significant (P < 0.005). It has increased by 2.2 cm in the past 12 months, and the data further illustrate the beneficial effect of vosoritide on height. (Bio Valley) Bioon.com )
Source: biomrin submissions marketing authorization application to European Medicine Agency for vosoritide to treat children with achondroplasia
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