RLYP black box warning wonderingsI don’t see any comments in any of the threads about this, following up Dr. KSS’ writings about RLYP. In late October the Hyperkalemia drug Veltassa was approved for sale in the U.S., but with a caveat.
This from the Motley Fool on Oct. 22:
”While FDA approvals usually send a stock soaring higher, investors appear to be spooked by the black-box warning that was included. The warning noted that Veltassa binds to other drugs that are taken orally, which could decrease their absorption and potentially reduce their effectiveness, so the approval stated that no other oral medications should be administered to patients at least 6 hours before or after Veltassa is taken.” The MF article went on to mention that following this news, the RLYP price dropped, then rose 50% in the last week, while the ZSPH stock price (which had dropped a day or so earlier) rose as RLYP fell because of the possible advantage their drug may have, if it does not carry such a warning (Dr. KSS’ concerns about the drug noted).
I am interested in but have not invested in RLYP, just discovering it as I catch up on missed missives. Would like to read other Gummy perspectives on this latest twist.
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Hi pozoblue,
Everything I have read states that it is not surprising that Veltassa binds to other agents, as this is the nature of ion/resin binding drugs. It was surprising that Veltassa got a black box warning, but it may not be a concern at all … I have seen many doctors come out saying it would not affect their prescribing of the drug. Furthermore, many say the FDA is being overly cautious, and could also give ZS-9 a black box warning, as it is known to bind other agents as well (although maybe not so non-specifically). Finally, Relypsa $RLYP is expected to release drug-drug interaction data in Q1 of 2016, so this could clear up some of the confusion and maybe even offer reason for the FDA to change or remove the black box warning.
I’m sure Dr. KSS has addressed all of these things somewhere. I advise you perform a “control + F” search of “$RLYP” in past articles. He may or may not see this post.
Disclosure : I am long $RLYP
Over at Seeking Alpha, White Coat Mafia has gone into massive detail on RYLP. The articles and comments are excellent.
As far as black-box warnings go, that one is comparatively mild, the same could be said for taking any medication along with grapefruit juice. At least it doesn’t directly result in dangerous side effects, just a chance of reduced effectiveness.