`
`Novartis completes safety review and initiates update to the Beovu® prescribing information worldwide I Novartis
`
`Patients I Healthcare Professionals I Media I Investors I Partners I ESG I Job Seekers I Clinical Trials ik Coronavirus 141 Global v
`
`0 NOVARTIS
`
`Novartis completes safety review and initiates
`update to the Beovu® prescribing information worldwide
`
`Apr 08, 2020
`
`Basel, April 08, 2020 — Patient safety is at the heart of everything we do. Whenever adverse events are reported,
`we take them seriously and investigate them thoroughly.
`
`As part of its safety surveillance program, Novartis has been actively evaluating post-marketing cases reported as
`severe vision loss, retinal artery occlusion and/or vasculitis with Beovu''' (brolucizumab). We have been working
`closely with the reporting physicians and retina specialists to get their perspective and collect the relevant clinical
`and imaging data in a manner compliant with regulatory requirements.
`
`Novartis has now completed its review of these post-marketing safety case reports. This included assessment by an
`external Safety Review Committee (SRC) chartered to provide independent, objective and thorough scientific review
`of the reported post-marketing adverse events in comparison to relevant events seen in the Phase III Hawk and
`Harrier registration trials that were the basis of the approved prescribing information. Based on internal and SRC
`assessment, Novartis concluded that there is a confirmed safety signal of rare adverse events of "retinal vasculitis
`and/or retinal vascular occlusion that may result in severe vision loss." Typically these events occur in the presence
`of intraocular inflammation.*
`
`Based on this review, Novartis has initiated a safety information update to Beovu prescribing information worldwide.
`Currently approved prescribing information includes intraocular inflammations, visual acuity decrease (including
`blindness) and retinal artery occlusion as separate terms. We will work with regulatory authorities to finalize the
`prescribing information update.
`
`In addition, we are working with our data monitoring committees and informing investigators of ongoing clinical trials.
`Novartis-sponsored studies will be amended so that protocols, Informed Consent Forms and Investigator Brochures
`reflect this new safety information. Investigators are also being informed to re-consent patients.
`
`We are committed to continuing to collaborate with the scientific and broader retina community to better understand
`the root causes and potential risk factors associated with these rare adverse events. Novartis continues to believe
`Beovu represents an important treatment option for patients with wet AMD, with an overall favorable benefit-risk
`profile.
`
`We would like to thank all doctors who took the time to upload clinical data and images and we encourage physicians
`to continue to report any adverse or suspicious events in accordance with local requirements at
`https://www.report.novartis.com (https://www.report.novartis.com). To ensure that healthcare providers have the
`information they need to manage wet AMD patients, we will continue to provide updates on
`https://www.brolucizumab.info (https://www.brolucizumab.info).
`
`This website intends to use cookies to improve the site and your experience. By continuing to browse the site
`you are agreeing to accept our use of cookies. If you require further information and/or do not wish to have
`cookies placed when using the site, visit About Cookies page.
`
`X
`
`https://www.novartis.com/news/novartis-completes-safety-review-and-initiates-update-beovu-prescribing-information-worldwide
`
`1/2
`
`REGITC00376214
`Regeneron Exhibit 1250.001
`Regeneron v. Novartis
`IPR2021-00816
`
`
`
`10/20/2020
`
`Novartis completes safety review and initiates update to the BeovuO prescribing information worldwide I Novartis
`
`Related Links
`
`Innovative Medicines (/news/noyartis-corporate-fact-sheet/innoyatiye-medicines)
`Global Health & Corporate Responsibility (/news/noyartis-corporate-fact-sheet/global-health-corporate-responsibility)
`Ophthalmology (/our-science/research-disease-areas/ophthalmology)
`Ethics, Risk and Compliance (/our-company/corporate-responsibility/ethics-risk-compliance)
`
`© 2020 Novartis AGTerms of Use I Privacy Policy I Contact Us I Site MapThis site is intended for a global audience.
`
`This website intends to use cookies to improve the site and your experience. By continuing to browse the site
`you are agreeing to accept our use of cookies. If you require further information and/or do not wish to have
`cookies placed when using the site, visit About Cookies page.
`
`https://www.novartis.com/news/novartis-completes-safety-review-and-initiates-update-beovu-prescribing-information-worldwide
`
`2/2
`
`REGITC00376215
`Regeneron Exhibit 1250.002
`Regeneron v. Novartis
`IPR2021-00816
`
`
Accessing this document will incur an additional charge of $.
After purchase, you can access this document again without charge.
Accept $ Charge
Still Working On It
This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.
Give it another minute or two to complete, and then try the refresh button.
A few More Minutes ... Still Working
It can take up to 5 minutes for us to download a document if the court servers are running slowly.
Thank you for your continued patience.
This document could not be displayed.
We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.
Your account does not support viewing this document.
You need a Paid Account to view this document. Click here to change your account type.
Your account does not support viewing this document.
Set your membership
status to view this document.
With a Docket Alarm membership, you'll
get a whole lot more, including:
- Up-to-date information for this case.
- Email alerts whenever there is an update.
- Full text search for other cases.
- Get email alerts whenever a new case matches your search.
One Moment Please
The filing “” is large (MB) and is being downloaded.
Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.
Your document is on its way!
If you do not receive the document in five minutes, contact support at support@docketalarm.com.
Sealed Document
We are unable to display this document, it may be under a court ordered seal.
If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.
Access Government Site
