Advicenne Updates on Availability of Sibnayal® to Patients and Caregivers in Great Britain – Yahoo Finance

PARIS, September 14, 2022–(BUSINESS WIRE)–Regulatory News:
Advicenne (Euronext Growth Paris ALDVI – FR0013296746), a specialty pharmaceutical company dedicated to developing and commercializing innovative treatments for those suffering from rare renal diseases, is pleased to update about the market access of Sibnayal® in Great Britain. Sibnayal® is a combination of potassium citrate and potassium bicarbonate.
Sibnayal® has been accepted for use within NHS Scotland. This positive decision by the Scottish Medicines Consortium (SMC) makes Sibnayal® immediately available to all Scottish distal Renal Tubular Acidosis (dRTA) patients as per the licensed indication. This decision validates the medical contribution of Sibnayal® and its favorable cost/benefit ratio in treating dRTA.
In England, Advicenne has withdrawn its submission to the National Institute for Health and Care Excellence (NICE). The current absence of long-term outcome data for dRTA patients precluded a robust health economic model to be provided to NICE. Therefore, in England, Advicenne will work directly with specialist centers to make Sibnayal® available to treat dRTA patients.
Advicenne believes that the economic impact of this decision will be limited given the limited number of prescribers and hospitals requiring local access to Sibnayal®. In addition, Advicenne, within the framework of the European registry of patients suffering from dRTA, plans to collect data that will support a new submission to the NICE and provide the necessary long-term outcomes data.
Didier Laurens, Chief Executive Officer of Advicenne, commented: « We are very pleased with the availability of Sibnayal® to patients and caregivers in Great Britain. The Scottish decision validates the major therapeutic contribution of our drug and our economic vision for the product. Regarding NICE, we are confident that we will be able to meet their health-economic requirements in the future. Most importantly, patients and caregivers in Great Britain now have access to a drug which will benefit their daily lives. This announcement is a new step in Sibnayal®’s European business network, the aim is to maintain maximum value either via Advicenne as is the case in Great Britain or commercial partnerships
Sibnayal® ‘s availability for sale was announced in Great Britain in June 2022. Advicenne has set up the GB organization to support the commercial success of the product in terms of commercial, medical, and logistics.
About Advicenne
Advicenne (Euronext: ALDVI) is a specialty pharmaceutical company founded in 2007, specializing in the development of innovative treatments in Nephrology. Its lead product Sibnayal® (ADV 7103) has received its Marketing Approval for distal renal tubular acidosis in EU and the UK. ADV 7103 is currently in late-stage development in cystinuria in Europe and in dRTA and cystinuria in the US and in Canada. Headquartered in Paris, Advicenne, listed on the Euronext Paris stock exchange since 2017, has now been listed on Euronext Growth Paris since its transfer on March 30, 2022. For additional information see: https://advicenne.com/.
Disclaimer
This press release contains certain forward-looking statements concerning Advicenne group and its business, including its prospects and product candidate development. Such forward-looking statements are based on assumptions that Advicenne considers to be reasonable. However, there can be no assurance that the estimates contained in such forward-looking statements will be verified, which estimates are subject to numerous risks including the risks set forth in the 2021 Universal Registration Document filed with the French financial market authority on April 29, 2022 (a copy of which is available on www.advicenne.com) and to the development of economic conditions, financial markets, and the markets in which Advicenne operates. The forward-looking statements contained in this press release are also subject to risks not yet known to Advicenne or not currently considered material by Advicenne. The occurrence of all or part of such risks could cause actual results, financial conditions, performance, or achievements of Advicenne to be materially different from such forward-looking statements. Advicenne expressly declines any obligation to update such forward-looking statements.
View source version on businesswire.com: https://www.businesswire.com/news/home/20220913006243/en/
Contacts
Advicenne
Didier Laurens, CEO
+33 (0)1 87 44 40 17
Email: [email protected]
Ulysse Communication
Media relations
Bruno Arabian
+33 (0)6 87 88 47 26
Email: [email protected]
Related Quotes
In Q2, HIV drugs generated more than two-thirds of its total revenue. If you delve further into the details, you'll see that two drugs — Biktarvy and, to a lesser extent, Descovy — appear to be cannibalizing sales of Gilead's other HIV drugs. Gilead is also partnering with Gritstone Bio to evaluate an experimental HIV therapeutic vaccine in an early-stage clinical study.
The FDA approval of Sotyktu for psoriasis has ignited and dampened prospects for smaller biotech stocks.
Clovis (CLVS) files regulatory applications in the United States and Europe seeking label expansion for its sole marketed drug as a first-line maintenance treatment in advanced ovarian cancer.
There is little enthusiasm about coming study results for treatments targeting the protein amyloid beta, so there is upside for risk-seeking investors.
Novavax (NVAX) gets authorization from the European Union to use its COVID-19 vaccine as a booster dose in adults.
New data from the first of a new type of cancer drug suggest its benefits and limitations, while leaving room for other candidates seeking to enter the lucrative market. Amgen lung-cancer pill Lumakras beat out a common chemotherapy in a late-stage study, helping patients survive without their tumors getting worse, though it failed to prove that it reduced overall deaths, the company said. The Food and Drug Administration conditionally approved Lumakras last year based on encouraging early-stage study data but required Amgen to conduct a confirmatory study, which the company reported Sunday.
Valeo Pharma Inc. (TSX: VPH) (OTCQB: VPHIF) (FSE: VP2) ("Valeo" or the "Company"), a Canadian pharmaceutical company, announced today that it has entered into a Commercial Services Agreement with Veru Inc. (Veru) for sabizabulin for COVID-19 in Canada. Sabizabulin is a novel dual antiviral and anti-inflammatory agent being targeted for the treatment of hospitalized moderate-severe COVID-19 patients at high risk for acute respiratory distress syndrome (ARDS) and death.
With more than 17 million Americans with NASH, the fatty liver disease has been a prime target for drug developers. But few have been able to show promising clinical trial results.
Ideaya Biosciences (IDYA) reports positive interim results from its mid-stage study, evaluating darovasertib in combination with Pfizer's Xalkori (crizotinib) in metastatic uveal melanoma. Stock up.
Regulus Therapeutics (RGLS) reports positive top-line data from a phase I single-dose ascending study of its lead candidate RGLS8429 in autosomal dominant polycystic kidney disease.
The FDA schedules a joint advisory committee meeting in November 2022 to review Perrigo's (PRGO) regulatory filing for the first-ever over-the-counter birth control pill.
Horizon's (HZNP) phase II study on dazodalibep for treating patients with Sjogren's syndrome meets the primary endpoint.
It’s safe to schedule your COVID booster and flu shot at the same time—and smart, experts say.
The August Consumer Price Index suggests the cost of health insurance has spiked. But the reality is more complicated.
Lantern Pharma Inc (NASDAQ: LTRN) will present preclinical data on the in vivo efficacy of its drug candidate LP-184 for pancreatic cancer at the American Association for Cancer Research Special Conference. LP-184 is a small molecule drug candidate and next-generation acylfulvene that preferentially damages DNA in cancer cells harboring mutations in DNA damage repair (DDR) genes and overexpressing the enzyme PTGR1. Pancreatic cancer cells are expected to be sensitive to LP-184 treatment, as arou
The FDA accepts and grants priority review to Acadia's (ACAD) NDA for trofinetide to treat Rett syndrome. A decision from the regulatory body is due on Mar 12, 2023.
Rhea Seehorn told PEOPLE that when she visited Bob Odenkirk in ICU the following day she thought, "I get another day [with him]"
Edgewise (EWTX) stock gains on upbeat interim results from the ARCH study of its lead candidate EDG-5506 in adults with Becker Muscular Dystrophy (BMD).
WASHINGTON, DC – MAY 03: Pro-choice demonstrators, including Emma Harris, left, and Ellie Small, center, both students at George Washington University gather in front of the Supreme Court of the United States on Tuesday, May 3, 2022 in Washington, DC. In a leaked initial draft majority opinion obtained and published by Politico, and authenticated by Supreme Court Chief Justice John Roberts Supreme Court Justice Samuel Alito wrote that the cases Roe v. Wade and Planned Parenthood of Southeastern
It’s common knowledge that excessive drinking can lead to a whole host of health problems: High blood pressure, heart disease, digestive issues, liver disease and the list goes on. Aside from excessive alcohol consumption, there are other habits that could be harming your liver, too—many of which …

source

Leave a Reply

Your email address will not be published.