|I had 1k invested in CALLS lol all going to ZERO . I hope i get back all in from AXON soon . Re: FDA thumbs down for now on rheumatoid arthritis drug|
| Reply to blacksheep - Msg #2670961 - 04/14/2017 12:07|
FDA thumbs down for now on rheumatoid arthritis drug
The FDA has rejected Eli Lilly’s blockbuster contender baricitinib, saying that the pharma giant will need to gather significantly more data before regulators will reconsider their decision.
According to a statement from Lilly, the pharma giant will not only need to provide more clinical data on the appropriate doses to be used for rheumatoid arthritis, regulators are also demanding more safety data, which could significantly delay any response to the CRL. Lilly says it disagreed with the FDA’s conclusion and the rejection.
The kickback marks a stunning setback for Eli Lilly $LLY CEO Dave Ricks, who owes investors a string of promised approvals following a long drought in the clinic. The pharma giant is known for its careful, if slow, approach to late-stage development. Baricitinib has been tagged as one of the top blockbusters in late-stage development and an important new drug for Lilly.
The rejection is also a setback for its biotech partner, Incyte $INCY, which licensed out the drug to Lilly 8 years ago for $90 million upfront. Analysts have pegged this as a potential blockbuster capable of earning up to $2 billion in peak annual sales, but that’s another number that is likely to get a serious review.
Both of these companies face a drubbing on Wall Street, but Lilly chose to release the news on the morning of Good Friday, a bank holiday. Lilly’s John Lechleiter initially promised investors at least two new drug approvals per year beginning in 2013, but had to delay on delivering until 2014. The company has also had three straight late-stage failures for solanezumab in Alzheimer’s disease.
The rejection provides Regeneron and its partners at Sanofi a chance to overcome its recent rejection on sarilumab — for manufacturing reasons — and push ahead with a rival therapy that many analysts believe is the odds-on favorite. It also marks another advantage for AbbVie, which has been circling the wagons around Humira as it mounts a defense against new therapies biting off pieces of its multibillion dollar franchise therapy.
A new report from ICER took issue with the price for Humira, which it posted as a net of $40,415 a year. And ICER provided a thumbs up for baricitinib and sarilumab. ICER clearly prefers sarilumab on efficacy — though we don’t know the price — giving only a marginal stamp of approval to baricitinib.
“We are disappointed with this action. We remain confident in the benefit/risk of baricitinib as a new treatment option for adults with moderate-to-severe RA,” said Christi Shaw, president of Lilly Bio-Medicines. “We will continue to work with the FDA to determine a path forward and ultimately bring baricitinib to patients in the U.S.”