Catalyst Pharmaceuticals Receives Positive Decision from Appeals Court That Supports Orphan Drug Exclusivity for Firdapse® for LEMS
With this ruling, the 11th
“We are extremely pleased with the 11th Circuit Court’s decision and are hopeful that it brings to a close this case that is not just important for Catalyst, but for all patients living with rare diseases who depend on medicines that would not be available if not for the efforts and investment of pharmaceutical companies willing to pursue these indications,” said
Transitioning to Firdapse® – Information for Prescribers and Patients Available at 1-833-422-8259 and www.yourcatalystpathways.com
Catalyst Pathways®, as Catalyst’s patient services program, is only open for adults LEMS patients to enroll, but its staff is available to answer questions from the parents of pediatric LEMS patients and the physicians treating them on available access for pediatric LEMS patients to obtain Firdapse®. These include:
- Catalyst’s Expanded Access Program which can provide investigational product to pediatric LEMS patients.
- Catalyst will provide support if a prescriber wishes to file an investigator initiated Investigational New Drug Application (IND) with the FDA, including Catalyst providing investigational product once the physician’s IND is active.
- In addition, Catalyst will approach FDA to discuss expanding the Firdapse® approval to include pediatric LEMS, though any effort to do so will take time and is not guaranteed.
For the larger number of adult LEMS patients who have been receiving Ruzurgi® off-label, prescribers should call 1-833-422-8259 in order to obtain information on transitioning those patients to Firdapse® and the steps to enroll them in Catalyst Pathways®.
Firdapse® is currently being evaluated in clinical trials for the treatment of MuSK-MG and has received Orphan Drug Designation from the FDA for myasthenia gravis.
This press release contains forward-looking statements. Forward-looking statements involve known and unknown risks and uncertainties, which may cause Catalyst's actual results in future periods to differ materially from forecasted results. A number of factors, including (i) the extent to which this decision will affect the use of Firdapse® by LEMS patients, (ii) whether the FDA and/or Jacobus exercises their opportunities to appeal this decision, and (iii) those factors described in Catalyst's Annual Report on Form 10-K for the fiscal year 2020 and Catalyst's other filings with the U.S. Securities and Exchange Commission (SEC), could adversely affect Catalyst. Copies of Catalyst's filings with the SEC are available from the SEC, may be found on Catalyst's website, or may be obtained upon request from Catalyst. Catalyst does not undertake any obligation to update the information contained herein, which speaks only as of this date.
David Schull Russo Partners(212) 845-4271 firstname.lastname@example.org Company Contact Patrick J. McEnany Catalyst PharmaceuticalsChief Executive Officer (305) 420-3200 email@example.com
Source: Catalyst Pharmaceuticals, Inc.