The FDA's thinking on Aduhelm
The FDA released documents that shed light on the how the agency came to its recent decision to approve Biogen and Eisai's Aduhelm.
It appears unlikely, however, that this new information will do much to quell the controversy around Aduhelm's approval.
The most notable disclosure is the FDA's decision to use November's advisory committee meeting – where experts voted near unanimously to recommend against approval – as a 'reset point' in their deliberations. It was at this moment, the documents reveal, that the agency began considering use of the accelerated approval pathway.
In a move predicted by many who have been critical of the FDA’s actions, Eli Lilly announced on Thursday that it will seek US approval for its own beta-amyloid targeting Alzheimer’s therapy donanemab based on mid-stage clinical data, having previously said it would await Phase III results to read out before filing.
Bristol Myers Squibb's recent deal with Eisai shows that antibody-drug conjugates (ADC) remain enticing in-licensing opportunities for Big Pharma companies.
The $650 million that Bristol Myers Squibb will initially pay for co-development rights to MORAb-202 is one of the highest upfront amounts paid for a Phase I drug. It hopes to start registrational studies next year and therapies like this one, which target folate receptor alpha (FRα), are most advanced for ovarian cancer.
In recent years, Bristol Myers Squibb has looked to broaden the focus of its oncology portfolio and pipeline through a combination of very large (the acquisition of Celgene) and smaller deals. Perhaps wounded by previous setbacks to its Opdivo franchise, which weighed down sentiment towards the company as a whole, management has chosen to spread development-related risk across multiple assets and treatment modalities.
GSK takes the shackles off
After consistently underperforming its peers during the past four years, GlaxoSmithKline CEO Emma Walmsley outlined a series of measures that she said would allow the company to deliver a 'step change' in performance over the next decade.
These include a 30% cut to the shareholder dividend (one of only three dividend cuts in the Big Pharma universe over the past 25 years, note analysts at Wolfe Research) and the already scheduled spin out of GlaxoSmithKline's consumer health business next year; with GlaxoSmithKline proposing to quickly sell its remaining 20% stake.
This will provide the company capital to pursue external development opportunities more aggressively alongside ambitious long-term sales forecasts for products already in the late-stage pipeline. These echo similar claims made by AstraZeneca back in 2014, though GlaxoSmithKline would do well to match the performance of its UK rival in recent years.
Intellia sets lofty ambitions in CAR-T
The advent of marketed CAR-T therapies has earned a lot of plaudits for the scientific progress they represent, but commercial challenges persist, fuelling significant investment in the allogeneic cell therapy field.
The latest entrant is Intellia Therapeutics, which has made a name for itself as a gene editing leader. It hopes to use its expertise in this field to unlock the potential of 'off the shelf' CAR-T therapies in partnership with Cellex Cell Professionals and its subsidiary GEMoaB, with funding from Blackstone Life Sciences.
Intellia says that the technology it is developing with GEM0aB is designed to reduce toxicities, such as lymphodepletion and immunodeficiency, target cells and tissues that have been previously hard to address and could allow the new company to leapfrog other CAR-T modalities.
Zuranolone: reasons to be hopeful
When Sage Therapeutics announced new Phase III data for its investigational depression drug zuranolone last week, many investors were quick to write off the results as underwhelming.
However, feedback from our snap-poll of US psychiatrists suggests that zuranolone could still have a decent size role to play in the depression market, thanks to being an active drug with a novel mechanism of action.
That said, Sage and its partner Biogen could face a challenge securing approval without additional data, one expert told FirstWord this week. He cited the need for a late-stage study looking at longer-term dosing versus the shorter intermittent dosing that Sage has so far prioritised, though said the latter could be a key selling point for zuranolone if it does reach the market.
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