FDA rejected HDV drug made by Gilead owned company in Germany

I wonder what are the FDA case here… they cited manufacturing and delivery issue….this come out the same day Gilead reported 5% decrease of revenue….

But……

  • As of September 30, 2022, Gilead had $6.9 billion of cash, cash equivalents and marketable debt securities down from $7.8 billion as of December 31, 2021.

Wow, not sure what is going on here, but Gilead seem to be resubmitting. I’m sure there will be a point soon that it will be approved, it doesn’t look like it’s due to the safety aspect but instead the production somehow. Perhaps @john.tavis has a bit more idea around this?

By the way, the last line is particularly bad: “transmitted through broken skin via sexual contact or contact with tainted syringes” is not right for most cases…

TT

1 Like

These press releases always have to be taken with a grain of salt. It is worth pointing out that production control by the EMA, BFARM (Germany) and ANSM (France) are at least as stringent and demanding as that of the FDA. Bulevirtide was granted conditional approval in the EU so its unclear how this could be an issue.

It is important to note that HDV rebound during bulevirtide therapy is now becoming increasingly prevalent in the patient populations in Europe now that we are seeing longer term exposure in these jurisdictions. This is an important concern as the large majority of patients have a significant proportion of HDV which is not affected by long term bulevirtide therapy. There is a concern amongst many physicians, some of which was voiced at the recent Deltacure meeting in Milan that viral rebound may occur in many of these patients.

Thanks @availlant ….HDV rebound is a big problem. I wonder if they are working to improve that…
Thanks for the info always!!

1 Like

Unfortunately, this is a fundamental issue with how bulevirtide works which cannot be corrected, even with increased dosing.

It is important to note here that there are no safety issues with bulevirtide and as noted in the Gilead press release, normalization of liver function does occur in 48% of patients. In the short term, lives hang in the balance with this co-infection so access to any intervention , even if only temporarily effective, is critical.

This is why are are making REP 2139-Mg available on a compassionate use basis to patients with very advanced liver disease (most of these have failed to respond to or experienced HDV rebound on 2 or 10mg bulevirtide)

1 Like

Thank you…agreed any intervention will help…in the meantime, we all looking forward to Rep 2139 MG…hopefully it will be ready and approved sooner than anticipated…2025!!

1 Like