AbbVie got the go-ahead to begin selling Rinvoq (upadacitinib), making it the third JAK inhibitor on the market for rheumatoid arthritis (RA) and potentially helping to ease the pressure on the company to begin backfilling for hole in its balance sheet set to appear in 2023 when Humira (adalimumab) biosimilars make their long-awaited appearance.
One notable feature of the approval was the language that FDA used in a black box warning included on Rinvoq’s label identifying thrombotic risk as an issue common to use of JAK inhibitors, which the Street took as a suggestion that Gilead Sciences and Galapagos may have a tough time avoiding a similar warning despite what the partners believe to be their agent’s best-in-class safety profile. More here.
In parallel, FirstWord conducted a pair of clinician polls this week, the first asking rheumatologists about their impression of all marketed RA drugs, and a second digging into how they plan on prescribing Rinvoq.
Farxiga strikes first blood in HF
AstraZeneca saw competing SGLT-2 inhibitors take the lead in proving they could reduce cardiovascular risk in diabetics, but the UK drugmaker laid down an initial marker of its own this week when Farxiga (dapagliflozin) achieved similar results in heart failure (HF) patients in the Phase III DAPA-HF trial.
Rivals in the class including Eli Lilly and Boehringer Ingelheim’s Jardiance (empagliflozin) are also being tested in this setting but AstraZeneca looks to be in line for a first-to-market status in what could prove to be a significant market if detailed results from DAPA-HF – to be presented at an upcoming medical meeting – live up to newly heightened expectations. More here.
Stay tuned as FirstWord is sitting down to discuss the impact of top-line DAPA-HF findings, along with potential implications for prescribing patterns in HF, with a key opinion leader early next week.
Keytruda’s NSCLC kingdom looks safe
Not to be outdone by a recent mixed readout for Bristol-Myers Squibb’s Opdivo (nivolumab), AstraZeneca revealed that Imfinzi (durvalumab) failed the Phase III NEPTUNE trial in front-line non-small-cell lung cancer (NSCLC), suggesting that Merck & Co.’s dominance with Keytruda (pembrolizumab) in the highly lucrative tumour type is looking a little more secure. More here.
Celgene comes bearing gift
Celgene is in the midst of being integrated in Bristol-Myers Squibb but as of this week it will arrive with one more value-driver in place after the FDA approved Inrebic (fedratinib) to treat myelofibrosis (MF). After a slew of missteps on the regulatory front, confirmation that the JAK2 inhibitor made it across the finish line is welcome news.
The announcement fell shy of a best-case scenario, as Inrebic’s label is saddled with a black box warning about encephalopathy risk, which will complicate any plans Celgene/Bristol-Myers Squibb may have had to compete with Incyte’s Jakafi (ruxolitinib) in the front-line MF setting. More here.
Sarepta’s sorry surprise
Sarepta Therapeutics shares tumbled 12% on August 19 after it received a complete response letter from the FDA for its golodirsen, and CEO Doug Ingram was not shy in expressing his surprise and disappointment with the agency’s decision, which he said was tied to two safety issues that had never been raised during discussions between the organisations.
The news may serve as an uncomfortable reminder of Sarepta’s experience with Exondys 51 (eteplirsen), which made it over the regulatory finish line – albeit only just after the FDA approved it over the objections of an AdComm and several of its own regulatory reviewers.
Ingram said Sarepta would immediately request a meeting with the FDA to discuss a path forward for golodirsen, which was designed to treat Duchenne muscular dystrophy (DMD) in patients with mutations amenable to exon 53 skip. though attention may begin to shift to an ongoing Phase III trial. The company will understandably hope to find an abbreviated path, however, as results are not expected until 2023 at the earliest.
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