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Sanofi

Sanofi

Sanofi is a french pharmaceutical company founded in 2004 by Madhukar Reddy.

Product

Cablivi

The single-domain antibody (sdAb) drug Cablivi (caplacizumab) combined with plasma exchange and immunosuppressive therapy, for the treatment of acquired thrombotic thrombocytopenic purpura (aTTP) adult patients with acquired thrombotic thrombocytopenic purpura. The approval makes Cablivi the first drug in the United States to specialize in the treatment of aTTP.



Cablivi was acquired after Sanofi spent $4.8 billion on Belgian biotechnology Ablynx, which was approved by the European Union at the end of August 2018 for adult patients who have experienced an aTTP attack. The approval makes Cablivi the world's first approved sdAb drug and the first drug specifically designed to treat aTTP. Cablivi has been granted orphan drug qualifications for the treatment of aTTP in the United States and the European Union, as well as fast-track qualifications and priority review qualifications in the United States.



The active drug component of Cablivi is caplacizumab, which is a potent and selective bivalent anti-von Willebrand factor (vWF) sdAb, which can block the interaction between very large vWF polymer (ULvWF) and platelets. It has an immediate effect on platelet aggregation and the subsequent formation and accumulation of small blood clots (microclot). In patients with aTTP, this tiny blood clot can lead to severe thrombocytopenia, tissue ischemia, and organ dysfunction. This transient effect of Cablivi (immediate effect,) can not only dismantle the potential disease process, but also protect the clinical manifestations of aTTP patients.



The approval of Cablivi was based on data from the Phase III Clinical study HERCULES (NCT02553317). The study was a randomized, double-blind, placebo-controlled study of 145 adult patients with aTTP. In the study, patients were randomly assigned to Cablivi or placebo and received standard care regimens (plasma exchange and immunosuppressive therapy).



The results showed that: (1) in terms of the main endpoints, Compared with placebo + standard nursing regimen, Cablivi combined with standard nursing regimen significantly shortened the time to normalize platelet count (p ≤ 0.01); at any particular time point during the study period, the possibility of reaching normal platelet count in Cablivi treatment group was. The placebo group was 1.55 times as much as the placebo group. (2) compared with placebo + standard nursing regimen, Cablivi combined with standard nursing regimen significantly reduced aTTP-related deaths, aTTP recurrence or at least one major thromboembolism event by 74 percent throughout the study period (p < 0.001). (3) during the whole study period, compared with placebo + standard nursing regimen, Cablivi combined with standard nursing regimen significantly reduced the recurrence of aTTP by 67% (p < 0.001). (4) throughout the study period, there were 0 refractory diseases in the Cablivi group and 3 refractory diseases in the placebo group, although there was no significant difference (p ≤ 0.06). (5) compared with the placebo group, the normalization of three organ injury markers (lactate dehydrogenase, cardiac troponin I, serum creatinine) occurred earlier in Cablivi group (p did not detect significant due to stratified statistical test). (6) the use of plasma exchange in Cablivi group was significantly lower than that in the placebo group (mean 5.8 days vs 9.4 days, a decrease of 38%). And stay in intensive care units (a decrease of 65 percent) and hospitals (a decrease of 31 percent) is even shorter. (7) the safety of Cablivi is consistent with previous reports and accords with its mechanism of action, including the increased risk of bleeding; the most common bleeding-related adverse events are epistaxis and gingival bleeding.

Timeline

2018

Sanofi launched its long-acting insulin product, Toujeo, in India.

People

Name
Role
LinkedIn

Madhukar Reddy

Founder



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News

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Date
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Description
Reuters Editorial
February 24, 2020
U.S.
Sanofi plans to create a standalone company dedicated to making active pharmaceutical ingredients (API), components that are biologically active in a drug, and will decide whether to list it on Euronext Paris by 2022.
Reuters Editorial
February 24, 2020
U.S.
Sanofi said on Monday it intended to create a standalone company dedicated to the production of active pharmaceutical ingredients.
Reuters Editorial
February 6, 2020
IN
French drugmaker Sanofi will announce a new coronavirus initiative within the next two weeks, its chief executive said on Thursday, adding that it wants to present something concrete and not add to "fantasies".
Matthias Blamont
February 6, 2020
U.S.
French drugmaker Sanofi on Thursday forecast further profit growth for 2020 even as it drops some research in areas such as diabetes in a shake-up to narrow its focus on blockbuster treatments including eczema medicine Dupixent.
Reuters Editorial
February 4, 2020
U.S.
French healthcare company Sanofi said on Tuesday it was being investigated over Depakine, an epilepsy drug which caused birth malfunctions and slow neurological development when taken during pregnancy.
Reuters Editorial
February 4, 2020
U.S.
French healthcare company Sanofi said it had been put under investigation over a legal case relating to Depakine, a medication known to have caused birth malfunctions and slow neurological development after being taken during pregnancy.
Lydia Ramsey
December 11, 2019
Business Insider
Sanofi is pulling back from its diabetes and heart business while going deep on potentially "transformative" treatments.
Matthias Blamont
December 9, 2019
IN
Sanofi on Monday said it would end its research efforts in diabetes and cardiovascular diseases as part of a reorganization plan that will narrow the number of its global business units in the hope of bolstering growth and profits.
Reuters Editorial
December 9, 2019
U.S.
Sanofi said on Monday it had agreed to buy California-headquartered biotechnology firm Synthorx in a cash deal worth about $2.5 billion aimed at beefing up the French drugmaker's pipeline of drugs for cancer and auto-immune disorders.
Reuters Editorial
December 9, 2019
U.S.
France's Sanofi said on Monday it had agreed to buy Synthorx in a cash deal worth around $2.5 billion as it seeks to beef up its immuno-oncology pipeline.
Reuters
December 2, 2019
@bsindia
Read more about Sanofi to sell surgical product unit Seprafilm to Baxter for $350 mn on Business Standard. The deal should close by the end of the first quarter of 2010, Baxter added in a statement confirming the purchase, which was reported earlier by Reuters
Silke Koltrowitz
November 25, 2019
IN
Swiss drugmaker Novartis is betting on heart drug prospect inclisiran in a $9.7 billion takeover of The Medicines Co as it challenges cardiovascular medicines from Amgen Inc , Sanofi and Regeneron Pharmaceuticals .
Reuters Editorial
November 22, 2019
U.S.
Sanofi's executive vice president in charge of strategy and business development, Muzammil Mansuri, a member of the French drugmaker's executive committee, will leave the firm by the end of the month, according to a memo seen by Reuters.
Arno Schuetze
November 21, 2019
U.S.
Sanofi is considering a joint venture or outright sale among options for its consumer healthcare unit, sources told Reuters, as the French drugmaker prepares to present a new strategic plan next month.
Matthias Blamont
October 31, 2019
IN
Sanofi expressed confidence for the fourth quarter and confirmed its full-year objectives on Thursday after posting lower third-quarter sales, hit by a fall in revenue at its primary care and vaccines businesses.
Tanya Lewis
October 28, 2019
Scientific American
Scientific American is the essential guide to the most awe-inspiring advances in science and technology, explaining how they change our understanding of the world and shape our lives.
October 15, 2019
WebWire
, , , , • One of the first digital manufacturing facilities in the world to use continuous, intensified biologics production technology, , • Framingham, Massachusetts facility will manufacture biologics for the Specialty Care portfolio, , • Successful process qualification runs completed in Q3 2019, , , , , , Sanofi today celebrates the inauguration of its new digital manufacturing facility in Framingham, Massachusetts, marking one of the world's first digital facilities using intensified, continuous...
Sohini Das
October 9, 2019
@bsindia
Read more about Nordisk and Sanofi log double-digit revenue growth in insulin pens on Business Standard. Around 6.98 million insulin pens were sold; it was 6.97 mn in the year-before period
Sohini Das & Samreen Ahmad
October 3, 2019
@bsindia
Read more about Biocon may replace plastic pens with reusables for insulin products on Business Standard. Biocon's ready-to-use pre-filled disposable pen with insulin Glargine is manufactured at its plant in Bengaluru.
Sandra E. Garcia
September 30, 2019
www.nytimes.com
The pharmacy chains pulled the heartburn medication from shelves after the Food and Drug Administration warned that it had detected low levels of a cancer-causing chemical in samples of the drug.
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