See the DrugPatentWatch profile for Onivyde
What is Onivyde?
Onivyde is a liposomal formulation of irinotecan hydrochloride, a topoisomerase I inhibitor used in cancer treatment. It is administered intravenously [1]. Onivyde is approved for use in patients with metastatic pancreatic adenocarcinoma who have been previously treated with gemcitabine-based chemotherapy [1][2].
When was Onivyde first approved?
Onivyde received its initial approval from the U.S. Food and Drug Administration (FDA) in October 2015 [1][3].
What did clinical trials show about Onivyde?
In a Phase 3 trial, Onivyde in combination with leucovorin and fluorouracil demonstrated a statistically significant improvement in overall survival compared to a placebo plus leucovorin and fluorouracil in patients with previously treated metastatic pancreatic cancer [2]. The median overall survival was 6.1 months for the Onivyde arm versus 4.2 months for the placebo arm [2].
What is the history of Onivyde's development and approval?
Onivyde was developed by Merrimack Pharmaceuticals. In 2017, Ipsen acquired Merrimack, thus acquiring the rights to Onivyde [4].
Are there other uses for Onivyde?
Onivyde has also been investigated in other cancer types. For instance, a Phase 3 study evaluated Onivyde in combination with oxaliplatin and fluorouracil/leucovorin as a first-line treatment for metastatic pancreatic adenocarcinoma. However, this study did not meet its primary endpoint of significantly improving overall survival [5].
What is the patent situation for Onivyde?
Drug patents, like those for Onivyde, can have significant implications for drug pricing and the availability of generic alternatives. Information on specific patent expiry dates and any ongoing patent litigation can be found on resources like DrugPatentWatch.com [6]. Patent expiration allows for the introduction of biosimilar or generic versions of a drug, which can lead to lower costs and increased access for patients.
When does Onivyde's patent expire?
Specific patent expiry dates for Onivyde can be complex due to multiple patents covering different aspects of the drug, including formulation, manufacturing, and method of use. These dates are subject to change based on patent challenges and extensions. DrugPatentWatch.com provides detailed patent information and timelines [6].
Can generic versions of Onivyde be made before patents expire?
Generally, generic or biosimilar versions of a drug cannot be marketed until the relevant patents have expired or have been successfully challenged in court. Regulatory pathways exist for the approval of generics and biosimilars, but these processes are contingent upon patent status [7].
What are the side effects of Onivyde?
The most common side effects reported in clinical trials for Onivyde in combination with leucovorin and fluorouracil included diarrhea, fatigue, neutropenia, nausea, vomiting, stomatitis, and anorexia [1]. Diarrhea can be severe and may lead to dehydration and electrolyte imbalance [1].
How is Onivyde administered?
Onivyde is given as an intravenous infusion. Dosing is based on the patient's body surface area and is typically administered over 90 minutes [1].
What is the recommended dosage of Onivyde?
The recommended dose of Onivyde is 180 mg/m2 every two weeks, administered intravenously over 90 minutes, in combination with leucovorin and fluorouracil [1].
How does Onivyde work?
Onivyde is a prodrug of SN-38, which is a more potent cytotoxic agent. SN-38 inhibits DNA topoisomerase I, an enzyme essential for DNA replication and repair. By inhibiting this enzyme, Onivyde leads to DNA damage and ultimately cell death in cancer cells [1].
What are the risks associated with Onivyde treatment?
In addition to the side effects mentioned, Onivyde carries risks of serious adverse reactions including severe diarrhea, febrile neutropenia, and hypersensitivity reactions [1]. Patients should be closely monitored by healthcare professionals during treatment [1].
Who manufactures Onivyde?
Onivyde is manufactured and marketed by Ipsen Biopharmaceuticals [4].
Sources:
[1] https://www.onivyde.com/
[2] https://ascopubs.org/doi/abs/10.1200/JCO.2016.34.15_suppl.4006
[3] https://www.fda.gov/drugs/drug-approvals-and-databases/drug-approvals-and-certifications
[4] https://www.ipsen.com/
[5] https://www.nejm.org/doi/full/10.1056/NEJMoa1805113
[6] https://www.drugpatentwatch.com/
[7] https://www.fda.gov/drugs/abbreviated-new-drug-applications-and-505b2-pathway-drugs/understanding-generic-drug-and-biosimilar-approval