AnHeart Therapeutic’s Global Early Access Policy
AnHeart Therapeutics is a clinical-stage biopharmaceutical company developing novel precision medicines for cancer. Our mission is to improve the lives of people with cancer.
To realize our mission, we must conduct the research and clinical trials necessary to evaluate the safety and effectiveness of our investigational medicines. We believe that rigorous clinical trials are the most appropriate way to do this. If successful, data from these studies may be used to seek potential approval from regulatory authorities (such as the U.S. FDA and China NMPA) – with the ultimate goal of making our medicines available to as many eligible patients as safely and quickly as possible.
More information about AnHeart Therapeutics’ ongoing clinical trials can be found by visiting https://www.anhearttherapeutics.com/clinical-trials/.
We recognize that, in some cases, patients with serious or life-threating diseases may not be eligible for clinical trials and may have exhausted all other treatment options. If a patient is not eligible for an investigational medicine through a clinical trial, they may be able to access an investigational medicine via an early access program, if available.
General Criteria
When considering offering early access to our investigational therapies, AnHeart Therapeutics undertakes careful consideration of many factors, including: the safety and effectiveness of our therapies as they continue to be evaluated in clinical trials; and our manufacturing capabilities and drug supply capacity. Additional criteria we consider include:
- The AnHeart Therapeutics investigational therapy must be in active development in clinical trials.
- The disease must be serious or life-threatening and the person must not be eligible for any ongoing clinical trials or other approved therapies.
- There is sufficient clinical evidence that suggests the potential benefit to the patient would likely outweigh the potential risks, based on available safety and efficacy information of the investigational therapy being developed by AnHeart Therapeutics.
- There is sufficient evidence to identify an appropriate dose for early access use.
- Granting early access would be unlikely to compromise, interfere with or delay the development programs, ongoing clinical trials, or regulatory filings designed to make the therapy available to many more patients.
- Early access to Anheart Therapeutics’ investigational medicines must comply with relevant country-specific ethical guidelines and regulations.
How to Request Access
While we understand the urgency for access to novel precision medicines for cancer, we believe the most appropriate way to access our investigational medicines is to participate in clinical trials regulated by the FDA and other global regulatory authorities. AnHeart Therapeutics does not currently have an expanded access protocol available for any of its investigational medicines. Requests for early access via a single patient IND (sIND) may be considered.
If you are seeking compassionate use of an AnHeart Therapeutics investigational medicine, please follow these steps:
- Review the criteria for consideration of access listed above.
- Ask the patient’s qualified treating doctor to make a formal request to AnHeart Therapeutics at earlyaccess@anhearttherapeutics.com.
How Decisions are Made
AnHeart Therapeutics is committed to a fair and impartial evaluation of each request for access to our medicines. All decisions are based on clinical circumstances and are guided by the principles outlined above.
Whenever possible, patients will be referred to ongoing clinical trials as the primary way to access our investigational medicines.
Decisions regarding potential early access to investigational or unapproved medicines can only be made, in certain circumstances, after in-depth discussions between AnHeart Therapeutics’ clinical teams and the patient’s qualified treating doctor acting on their behalf.
If you have additional questions, please speak with your doctor, or have your doctor contact earlyaccess@anhearttherapeutics.com. We anticipate acknowledging receipt of requests sent to this email within five business days.
In line with the 21st Century Cures Act, AnHeart Therapeutics, Inc., may revise this policy at any time.
