View all newsletters
Receive our newsletter - data, insights and analysis delivered to you
  1. News
April 5, 2017

RedHill Biopharma’s Yeliva obtains orphan drug designation from US FDA

RedHill Biopharma’s Yeliva (ABC294640) has secured orphan drug designation from the US Food and Drug Administration (FDA) for the treatment of cholangiocarcinoma.

RedHill Biopharma’s Yeliva (ABC294640) has secured orphan drug designation from the US Food and Drug Administration (FDA) for the treatment of cholangiocarcinoma.

Free Report
img

How is the Biopharmaceutical industry evolving?

2021 was a year of continued innovation and change in the Biopharmaceutical industry. As the COVID-19 pandemic continues to take its toll on businesses worldwide, it’s time to look for new ways to create value, prepare for the future, and remain competitive in the ever-changing landscape. GlobalData’s expansive report examines the business environment and trends that shape the Biopharmaceutical industry. We highlight the most impactful emerging technologies, as well as the industry, regulatory, and macroeconomic factors that influence growth prospects. Access the report to:
  • Benchmark the impact of major themes on the Biopharmaceutical industry.
  • Gain a deeper "on the ground" perspective through exclusive opinions and analysis from industry respondents.
  • Evaluate the effects of COVID-19 on the sector.
Download the full report to understand what to expect and how to align your strategies for success.
by GlobalData
Enter your details here to receive your free Report.

The company will benefit from the designation by various development incentives to develop Yeliva for the indication.

If approved, it will acquire a seven-year marketing exclusivity period to treat cholangiocarcinoma.

RedHill oncology medical director Mark Levitt said: “Cholangiocarcinoma is a cancer with a poor prognosis. Patients suffering from this disease have very few treatment options, and they are of limited efficacy.

“We are very pleased with the Orphan Drug designation and are advancing our preparations for a Phase IIa study to evaluate the safety and efficacy of Yeliva in patients suffering from unresectable, intrahepatic and extrahepatic cholangiocarcinoma, which we plan to initiate in the third quarter of this year.”

"Cholangiocarcinoma is a cancer with a poor prognosis. Patients suffering from this disease have very few treatment options, and they are of limited efficacy."

The Phase II-stage, orally administered sphingosine kinase-2 (SK2) selective inhibitor with anti-cancer and anti-inflammatory activities Yeliva targets multiple oncology, inflammatory and gastrointestinal indications.

When the SK2 enzyme is inhibited, Yeliva blocks the synthesis of sphingosine 1-phosphate (S1P), a lipid signalling molecule that promotes cancer growth, as well as pathological inflammation.

Every year, about 8,000 people are diagnosed with intrahepatic and extrahepatic bile duct cancers in the US and recent studies showed an increased incidence of cholangiocarcinoma.

The Phase I study with Yeliva was conducted at the Medical University of South Carolina (MUSC) Hollings Cancer Center in patients with advanced solid tumours.

Final results confirmed that the study met its primary and secondary endpoints and demonstrated that the drug is well-tolerated and can be safely administered to cancer patients in doses.

In the third quarter of this year, the company is planning to initiate a Phase IIa clinical study with Yeliva in patients with advanced, unresectable, intrahepatic and extrahepatic cholangiocarcinoma.

Related Companies

Free Report
img

How is the Biopharmaceutical industry evolving?

2021 was a year of continued innovation and change in the Biopharmaceutical industry. As the COVID-19 pandemic continues to take its toll on businesses worldwide, it’s time to look for new ways to create value, prepare for the future, and remain competitive in the ever-changing landscape. GlobalData’s expansive report examines the business environment and trends that shape the Biopharmaceutical industry. We highlight the most impactful emerging technologies, as well as the industry, regulatory, and macroeconomic factors that influence growth prospects. Access the report to:
  • Benchmark the impact of major themes on the Biopharmaceutical industry.
  • Gain a deeper "on the ground" perspective through exclusive opinions and analysis from industry respondents.
  • Evaluate the effects of COVID-19 on the sector.
Download the full report to understand what to expect and how to align your strategies for success.
by GlobalData
Enter your details here to receive your free Report.

NEWSLETTER Sign up Tick the boxes of the newsletters you would like to receive. A weekly roundup of the latest news and analysis, sent every Friday. The pharmaceutical industry's most comprehensive news and information delivered every month.
I consent to GlobalData UK Limited collecting my details provided via this form in accordance with the Privacy Policy
SUBSCRIBED

THANK YOU

Thank you for subscribing to Pharmaceutical Technology