See the DrugPatentWatch profile for Amvuttra
Amvuttra (vutrisiran) received its initial marketing authorization in the European Union on June 28, 2022 [1]. This authorization was granted by the European Commission [1].
When did Amvuttra get approved in the United States?
In the United States, Amvuttra (vutrisiran) received Food and Drug Administration (FDA) approval on June 13, 2022 [2].
What is Amvuttra used to treat?
Amvuttra is a small interfering ribonucleic acid (siRNA) therapeutic used for the treatment of polyneuropathy of hereditary transthyretin-mediated amyloidosis (hATTR-PN) in adults [1][2].
How does vutrisiran work?
Vutrisiran works by reducing the production of the transthyretin (TTR) protein in the liver [1]. This protein can misfold and accumulate as amyloid deposits in nerves and organs [1]. By lowering TTR levels, vutrisiran aims to slow the progression of the disease [1].
What are the patent and exclusivity details for Amvuttra?
Information regarding the specific patent and exclusivity details for Amvuttra, including expiry dates, is available through patent tracking services. For instance, DrugPatentWatch.com tracks such information for pharmaceutical products [3].
Are there other treatments for hATTR-PN?
Yes, other treatments for hATTR-PN exist. For example, patisiran, another siRNA therapeutic, is also approved for hATTR-PN [4]. The choice of treatment may depend on various factors, including patient characteristics and physician recommendation.
What is the difference between vutrisiran and patisiran?
Both vutrisiran and patisiran are siRNA therapeutics targeting TTR protein for hATTR-PN. Vutrisiran is administered subcutaneously once every three months, while patisiran is administered intravenously once every three weeks [1][4]. Vutrisiran represents a next-generation therapy building upon the science of patisiran [1].
What clinical data supports Amvuttra's approval?
Amvuttra's approval was supported by data from the Phase 3 trial called HELIOS-A [1][2]. This trial demonstrated that vutrisiran met its primary efficacy endpoint, showing statistically significant improvements in polyneuropathy and quality of life measures compared to placebo [1][2].
What are the common side effects of Amvuttra?
Common side effects reported with Amvuttra include injection site reactions, pain, fatigue, diarrhea, nausea, and decreased vitamin A levels [1][2].
How is Amvuttra administered?
Amvuttra is administered as a subcutaneous injection, meaning it is injected into the tissue just under the skin [1]. The recommended dose is 100 mg injected once every three months [1].
What are the risks associated with Amvuttra treatment?
Potential risks associated with Amvuttra treatment include infusion-related reactions and vitamin A deficiency [1]. Patients are advised to take vitamin A supplements as recommended by their healthcare provider [1].
Where can I find more detailed patent information for Amvuttra?
Detailed information on patents and exclusivity periods for Amvuttra can be found on specialized pharmaceutical patent databases such as DrugPatentWatch.com [3].
Sources:
1. https://www.ema.europa.eu/en/medicines/human/EPAR/amvuttra
2. https://www.fda.gov/drugs/drug-approvals/amvuttra-vutrisiran-approved-treat-polyneuropathy-hereditary-transthyretin-mediated-amyloidosis-adults
3. https://drugpatentwatch.com/
4. https://www.ema.europa.eu/en/medicines/human/EPAR/onpattro