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Ionis (IONS), AstraZeneca's Eplontersen Receives FDA Nod
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Ionis (IONS - Free Report) and partner AstraZeneca (AZN - Free Report) announced that the FDA has approved eplontersen for treating patients with hereditary transthyretin-mediated amyloid polyneuropathy commonly called hATTR-PN or ATTRv-PN. Eplontersen will be marketed by the name of Wainua.
ATTRv-PN is a debilitating disease, which leads to peripheral nerve damage and affects an estimated 40,000 people worldwide. It can cause motor disability within five years of diagnosis, which can become fatal if not treated properly within a decade.
The approval of Wainua was based on data from the NEURO-TTRansform study, which showed that treatment with Wainua led to consistent and sustained benefit, improving neuropathy impairment and quality of life. Wainua is expected to be launched in the United States in January 2024 as the companies had been preparing for this launch for sometime.
AstraZeneca and Ionis will market Wainua for ATTRv-PN in the United States, while AstraZeneca has exclusive rights to commercialize Wainua in outside U.S. markets.
Applications seeking approval of eplontersen for ATTRv-PN are under review in EU and some other countries.
Ionis’ stock was up 7% in pre-market trading on Thursday in response to the FDA approval for eplontersen as it was an important milestone for the company.
Ionis’ stock has risen 32.6% so far this year against a decrease of 4.4% for the industry.
Image Source: Zacks Investment Research
At present, Alnylam Pharmaceuticals' (ALNY - Free Report) Onpattro and Amvuttra are already approved for treating hATTR-PN. However, while Amvuttra has to be administered by a health care professional by subcutaneous injection once every three months, Wainua can be self-administered at home once a month via an auto-injector. AstraZeneca and Ionis believe that though the market is competitive, there is room for many players to succeed.
AstraZeneca and Ionis are also developing eplontersen for another form of amyloidosis called cardiomyopathy caused by hereditary TTR amyloidosis (ATTR-CM) in the phase III CARDIO-TTRansform study, which is on track for a data readout in first-half 2025. ATTR-CM is a larger opportunity for Wainua as worldwide, there are an estimated 300,000-500,000 patients suffering from the disease.
Ionis has a broad pipeline of partnered programs with Biogen (BIIB - Free Report) , AstraZeneca, Novartis, and GSK, among other large drugmakers.
Ionis has licensed Spinraza to Biogen, which is responsible for commercializing the drug approved for treating spinal muscular atrophy (SMA) worldwide. Ionis receives royalties from Biogen on Spinraza’s sales. Biogen has also expanded its collaboration with Ionis to identify new gene therapies for the treatment of SMA as well as a broad range of neurological diseases. Qalsody is the second marketed drug born under this partnership.
Pelacarsen is being developed in partnership with Novartis. Along with GSK, the company is evaluating bepirovirsen as a potential treatment for patients with chronic hepatitis B virus in two ongoing late-stage studies.
Image: Bigstock
Ionis (IONS), AstraZeneca's Eplontersen Receives FDA Nod
Ionis (IONS - Free Report) and partner AstraZeneca (AZN - Free Report) announced that the FDA has approved eplontersen for treating patients with hereditary transthyretin-mediated amyloid polyneuropathy commonly called hATTR-PN or ATTRv-PN. Eplontersen will be marketed by the name of Wainua.
ATTRv-PN is a debilitating disease, which leads to peripheral nerve damage and affects an estimated 40,000 people worldwide. It can cause motor disability within five years of diagnosis, which can become fatal if not treated properly within a decade.
The approval of Wainua was based on data from the NEURO-TTRansform study, which showed that treatment with Wainua led to consistent and sustained benefit, improving neuropathy impairment and quality of life. Wainua is expected to be launched in the United States in January 2024 as the companies had been preparing for this launch for sometime.
AstraZeneca and Ionis will market Wainua for ATTRv-PN in the United States, while AstraZeneca has exclusive rights to commercialize Wainua in outside U.S. markets.
Applications seeking approval of eplontersen for ATTRv-PN are under review in EU and some other countries.
Ionis’ stock was up 7% in pre-market trading on Thursday in response to the FDA approval for eplontersen as it was an important milestone for the company.
Ionis’ stock has risen 32.6% so far this year against a decrease of 4.4% for the industry.
Image Source: Zacks Investment Research
At present, Alnylam Pharmaceuticals' (ALNY - Free Report) Onpattro and Amvuttra are already approved for treating hATTR-PN. However, while Amvuttra has to be administered by a health care professional by subcutaneous injection once every three months, Wainua can be self-administered at home once a month via an auto-injector. AstraZeneca and Ionis believe that though the market is competitive, there is room for many players to succeed.
AstraZeneca and Ionis are also developing eplontersen for another form of amyloidosis called cardiomyopathy caused by hereditary TTR amyloidosis (ATTR-CM) in the phase III CARDIO-TTRansform study, which is on track for a data readout in first-half 2025. ATTR-CM is a larger opportunity for Wainua as worldwide, there are an estimated 300,000-500,000 patients suffering from the disease.
Ionis has a broad pipeline of partnered programs with Biogen (BIIB - Free Report) , AstraZeneca, Novartis, and GSK, among other large drugmakers.
Ionis has licensed Spinraza to Biogen, which is responsible for commercializing the drug approved for treating spinal muscular atrophy (SMA) worldwide. Ionis receives royalties from Biogen on Spinraza’s sales. Biogen has also expanded its collaboration with Ionis to identify new gene therapies for the treatment of SMA as well as a broad range of neurological diseases. Qalsody is the second marketed drug born under this partnership.
Pelacarsen is being developed in partnership with Novartis. Along with GSK, the company is evaluating bepirovirsen as a potential treatment for patients with chronic hepatitis B virus in two ongoing late-stage studies.
Zacks Rank
Ionis currently has a Zacks Rank #3 (Hold).
You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Ionis Pharmaceuticals, Inc. Price and Consensus
Ionis Pharmaceuticals, Inc. price-consensus-chart | Ionis Pharmaceuticals, Inc. Quote