Fra Maria Tornsen (President of North America) sitt innlegg på Q4. Synes hun oppsummerte mye nyttig informasjon på kort tid, det jeg merker meg er uthevet.
[…] The fourth quarter contained some significant events for Calliditas. As noted earlier, on December 20th, we received full approval for TARPEYO from the FDA. Our full approval label reflects the reduction of kidney loss in adults with IgAN at risk of disease progression. TARPEYO is the first and only product to receive this indication for the treatment of IgAN and our new label is based on the data that was published earlier in 2023 in The Lancet. As a reminder, our Phase 3 trial met the primary eGFR endpoint and demonstrated highly statistical significance. Having a full approval label increases our addressable market and in order to meet the growing market opportunity, we also made the decision to expand our commercial and medical organizations in Q3. Today, we have over 70 rare disease account managers who are responsible for the sales of TARPEYO. And we have also expanded other field functions such as reimbursement managers and thought leading liaisons, bringing our total field-based organization to around 100 employees. Already prior to the full approval, we had 90% payer coverage for TARPEYO, and with the new label in hand, our expanded payer and reimbursement team are engaging with US payers to ensure policies are updated to reflect the new indication.
[…] We are very excited about the opportunity ahead of us. We have already seen the very positive reaction the Phase 3 data has had on nephrologists when introduced to the strong clinical results of TARPEYO. We now have an opportunity to promote our full approval label with an increased presence across sales, reimbursement, marketing and medical affairs. While we anticipate the strong data to result in more enrollments, we do expect it will take some time for payers to update their policies, so the impact of the new label will be fully realized in the second half of 2024. We are also anticipating a seasonal impact to Q1 due to the open enrollment process, which is typical for this time of the year.
[…] In 2024, we are also expecting an update to the KDIGO treatment practice guidelines. These guidelines have the potential to broaden the definition of the at-risk population and also support the use of TARPEYO as the only fully approved drug with impact on eGFR. Today, we are already seeing that the majority of patients who reach nine months treatment continue on TARPEYO. And in the first half of 2024, we’re expecting new data from our Open Label Expansion trial. The Open Label Expansion data set will provide us with additional clinical information on the potential benefits of a repeat course of nine months of treatment with TARPEYO.
Kilde: SeekingAlpha
