DocWire News Editors

DocwireNews

This week, the FDA approved a new influenza treatment for the first time in the past two decades. Created by Roche Pharmaceuticals, Xofluza (baloxavir marboxil) is a single dose oral medication intended for patients of at least age 12. The medication is to be taken in the first two days after appearance of symptoms such as fever, sniffles, and aches.Roche claims that this Xofluza has utilizes a unique mechanism that inhibits polymerase acidic endomuclease, an integral enzyme to flu virus replication. The company&rsquo;s chief medical officer and head of global product development, Sandra Horning, expressed excitement about achieving the first <a href="https://proddocwire.wpengine.com/hematology-oncology/fda-approves-blood-compatibility/">FDA approval</a> of a <a href="https://proddocwire.wpengine.com/infectious-disease/influenza-virus/">flu medication</a> in 20 years. She adds that Roche takes pride in offering a convenient option for flu treatment that yields symptom improvement within one day.&ldquo;If patients see their doctors within 48 hours of symptom onset, one dose of Xofluza can significantly reduce the duration of flu symptoms,&rdquo; said Horning in a statement.Xofluza was tested via two randomized controlled clinical trials, including 1,832 patients who were assigned to either receive Xofluza, placebo, or other antiviral flu treatment within two days of symptom onset. Both trials found that those treated with Xofluza experienced symptom alleviation faster than those who took the placebo. The second trial found that those who used Xofluza overcame symptoms just as fast as those who took other flu medication, making this new and convenient treatment option an approval-worthy medication. In fact, the results from these trials were significant enough that the FDA granted Xofluza Priority Review, which fast tracks the approval process for drugs that may significantly improve effectiveness of treating serious conditions.&ldquo;This is the first new antiviral flu treatment with a novel mechanism of action approved by the FDA in nearly 20 years. With thousands of people getting the flu every year, and many people becoming seriously ill, having safe and effective treatment alternatives is critical. This novel drug provides an important, additional treatment option,&rdquo; said FDA Commissioner Scott Gottlieb, M.D.Gottlieb went on to emphasize that citizens should still receive seasonal flu vaccinations, being that vaccines are the most effective first-line preventative measure, whereas medications like Xofluza are designed to alleviate symptoms in those who have already contracted the flu.The oral medication will be sold at $150 per pill, as per a spokeswomen for Genentech, the company that will be selling Xofluza in the US. Genentech will also be offering coupons that decrease this price to $30 a pill for those with&nbsp; health insurance, and $90 for the uninsured.The pill will cost $150, according to a spokeswoman for Genentech, which will sell Xofluza in this country. Genentech will offer coupons that lower the price to $30 for patients with health insurance and to about $90 for the uninsured.<blockquote class="twitter-tweet" data-lang="en">
<a href="https://twitter.com/hashtag/FDA?src=hash&amp;ref_src=twsrc%5Etfw">#FDA</a> NEWS: Today <a href="https://twitter.com/hashtag/FDA?src=hash&amp;ref_src=twsrc%5Etfw">#FDA</a> approved a new antiviral flu treatment&mdash;the 1st flu treatment with a novel mechanism of action approved by FDA in ~20 yrs. With thousands in the U.S. who get the flu every year, having safe and effective treatment options is critical. <a href="https://t.co/zmSEpI1PAD">https://t.co/zmSEpI1PAD</a> <a href="https://t.co/tXZTFEiaIr">pic.twitter.com/tXZTFEiaIr</a>
&mdash; Scott Gottlieb, M.D. (@SGottliebFDA) <a href="https://twitter.com/SGottliebFDA/status/1055193340268953600?ref_src=twsrc%5Etfw">October 24, 2018</a>
</blockquote><script async src="https://platform.twitter.com/widgets.js" charset="utf-8"></script>For Additional Coverage <a href="https://proddocwire.wpengine.com/docwire-pick/fda-approves-baloxavir-marboxil/">Click Here</a>Sources: <a href="https://www.biospace.com/article/roche-snags-fda-approval-for-first-new-flu-drug-in-20-years/">BioSpace</a>, <a href="https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm624226.htm">FDA</a>, <a href="https://www.nytimes.com/2018/10/24/health/flu-pill-xofluza.html">NYTimes</a>

Jordana Jampel

Positive Preliminary Results From Phase 1 Trial of Dopaminergic Neuron Graft for Parkinson’s Disease

Dementia

Bradley Warady, MD

Joel M. Topf, MD, FACP

2025 Hume Award Winner Is Dedicated to Children’s Care

NKF Spring Clinical Meetings 2025

Distant Brain Metastases in Cutaneous Melanoma May Be Mitigated With Multiple Pathway Inhibitors

Melanoma

Latest News

FDA Approves First New Flu Treatment In 20 Years

Future of Medicine

This week, the FDA approved a new influenza treatment for the first time in the past two decades. Created by Roche Pharmaceuticals, Xofluza (baloxavir marboxil) is a single ...

About Us

Editorial Policy

Advertising

Contact Us

eNewsletters

Contribute

Career Center

MashupMD

Blood Cancers Today

Cancer Nursing Today

GU Oncology Now

Urban Health Today

Bile Duct Cancer

Colorectal Cancer

Gastroesophageal Cancer

Gastric Cancer

GEP-NETs

GIST

Liver Cancer

Pancreatic Cancer

GI Oncology Now

Anemia

Deep Vein Thrombosis

Essential Thrombocythemia

Hemophilia

Immune Thrombocytopenic Purpura

Myelodysplastic Syndromes

Myelofibrosis

Myeloproliferative Neoplasms

Polycythemia Vera

Pulmonary Embolism

Sickle Cell Disease

Thrombocytopenia

Thrombophilia

Thrombosis

Thrombotic Thrombocytopenic Purpura

Venous Thromboembolism

von Willebrand Disease

Heme Today

Acute Kidney Injury

ADPKD

Anemia and Kidney Disease

Chronic Kidney Disease

COVID-19 and Kidney Disease

Diabetes and Hypertension

End-Stage Renal Disease

Gout

Hyperkalemia

IgAN

Kidney Transplantation

Metabolic Acidosis

Nephrology Times

HER2 Breast Cancer

HR Breast Cancer

Triple-Negative Breast Cancer

Genetics & Breast Cancer

Breast Cancers Today

Atherosclerotic Disease

Atrial Fibrillation

Heart Failure

Hypertension

Interventional Cardiology

Lipid Management

Practice Tips With Dr. Lichaa

Preventive Cardiology

Stroke

Cardiology

Breast Cancer

Gynecologic Cancer

Head and Neck Cancer

Skin Cancer

Oncology

Sleep

Urology

Diabetes

Ophthalmology

— Demodex Blepharitis

Neurology

Rheumatology

Gastroenterology

Pulmonology

Infectious Diseases

— HIV

Health and Wellness

Lupus

Orthopedics

Pharmacology

Career News

More

Conferences

CardioNerds

The Sleep Source With Dr. Morse

Rheumatology Rounds With Dr. Maheswaranathan

Partners

Expert Interviews

Subscribe