Genmab — Juli 2020
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It´s ok to do it.
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Then we will have the information in the chat-history.
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we're very much looking forward to bringing ofatumumab to market. And we believe the FDA now has all the data they need to give us the green light. What is most compelling about ofatumumab is that it can give patients the possibility to live relapse-free for 9 to 10 years. What ofatumumab does is it effectively depletes B cells. This is the most efficacious way to treat MS. We've also developed this product specifically for MS with a favorable safety.
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It's also dosed precisely to sustain B cell depletion and it comes in a subcu injection. This has the potential to truly change how physicians treat MS in first line and first switch. Our focus in these past months has been to make it as easy as possible to prescribe and access this product.
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We've invested significantly in patient services and are rethinking our onboarding to make it seamless and flexible. Our launch will be tailored in a very different environment but with a very different approach, state-by-state, prescriber-by-prescriber. And as soon as we get the green light from FDA, we'll be ready to launch.
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-Yes. So the timing for ofa was based on, as you remember, the 3-month extension from the FDA. And the timelines currently are in the mid-September time frame. I don't have the exact date, but it's mid-September. And so we're negotiating the aspects of label with FDA. And we expect to reach those timelines, as Vas presented earlier.
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So we really feel that there's no better time to bring a highly efficacious and safe treatment that can be administered at home to MS patients considering the context. Our initial focus will be to really drive the broad adoption with MS specialists and general neurologists. And we're using a really highly agile approach between face-to-face and virtual outreach. We've actually developed a digital affinity score for physicians to understand where they are and how much digital promotion we can do.
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We're also leveraging our learnings from recent launches and facing significant focus on patient services to ensure seamless and flexible onboarding. So that's really -- our objective is to make sure that patients can access quickly and easily ofatumumab. We expect to see ramp-up in 2021 as we see the conversion of patients to product in ex U.S. towards the second half of 2021.
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A- Yes. So on Arzerra, I think the black box warning specifically refers to both PML cases and HBV reactivation. And looking at the mechanism of ofatumumab, if you think about the overall approach, what we've actually looked at for ofatumumab is the fastest B cell repletion. So when patients are actually receiving subcu injections,
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they have very low and very quick recovery of their B cells. So in return, in the studies for ASCLEPIOS I and II, we did not see any cases of PML and we also did not see any cases of HBV reactivation. So you can -- I think the FDA will accurately reflect what was in our ASCLEPIOS I and II studies. And I believe that will be the readthrough in terms of how we will have the label moving forward.
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Kiadis announces publication in Blood highlighting proof-of-concept to enhance potency of anti-CD38 antibodies with Kiadis’ K-NK004, recently licensed by Sanofi https://www.globenewswire.com/news-release/2020/07/22/2065517/0/en/Kiadis-announces-publication-in-Blood-highlighting-proof-of-concept-to-enhance-potency-of-anti-CD38-antibodies-with-Kiadis-K-NK004-recently-licensed-by-Sanofi.html
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Thanks for All the info E L
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Ditto from me.
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