Replies to post #131347 on Biotech Values

[genisi]

Xarelto in ACS data

Urche,
On the discordancy in dosing between Afib and ACS: different indications for different populations on different background therapy and I agree that an additional study will be required but IMO only in the overlap population.

On intracerebral hemorrhages: looking at Fig. 2 in the NEJM paper, the subgroup of patients with previous stroke or TIA had the worst data and I'd expect they also had the majority of intracranial hemorrhage events.

On NNT and NNH values, your calculations are correct and like you said, we're looking at mortality benefit vs. increased major bleeding but I believe it will be considered a significant net clinical benefit.

So, my point is that IMO the decision to use riva in ACS is far from clear cut.

I expect the FDA to have concerns with xarelto in ACS similar to your but my bet is the lower dose is approvable. Let's talk about the decision to use Xarelto in ACS if it gains approval in this indication :)

Respectfully,
Idit

[DewDiligence]

Re: Xarelto impact on Lovenox in ACS

Now that I’ve had time to read the NEJM article on the ATLAS ACS 2–TIMI 51 study (#msg-68962549), the accompanying NEJM editorial (#msg-68962549), the write-up in theHeart.org (#msg-68962285), and Bayer’s own PR on the study’s results (#msg-68953169), I think my prior estimate in #msg-68940203 that Xarelto will take 10% of Lovenox’s US market share in ACS was slightly off-base.

I now think Xarelto will take close to 0% of Lovenox’s market share in ACS.

The important point that no one mentioned in this discussion is that Xarelto’s phase-3 trial in ACS was restricted to secondary prevention. Patient enrollment in the trial began at a median of 4.7 days after the acute incident (MI or unstable angina), and actual treatment with Xarelto was delayed even further until a patient was deemed to be stabilized.

Thus, by the time Xarelto treatment in the ATLAS ACS 2–TIMI 51 study began, a patient was either discharged from the hospital or close to being discharged and the period in which Lovenox is customarily used had already run out.

(If Xarelto gets uptake for ACS in the outpatient setting, it will likely come at the expense of AZN’s Brilinta rather than any of the approved anticoagulants. I think Brilinta has a compelling case in this setting insofar as it obviates the need for either Xarelto or Plavix. Moreover, Xarelto probably won’t be used in patients with a prior stroke or TIA or with renal impairment.)

To be conservative, I’m leaving the arithmetic in paragraph E of #msg-68940203 unchanged, although I think the actual effect of Xarelto on US Lovenox sales in the ACS indication will be de minimis.