FDA 2023 NCE’s approvals- the sales roller coaster of post-launch
Ancient Greek philosopher Plato is known for well advanced thoughts and several master pieces that still resonate in the modern days across our daily lives, and how nations and states, organizations and corporate world are grounded to it. Plato made several different considerations about Mathematics, including one fine conceptual view, ‘the highest form of pure thought is mathematics’.
Whenever numbers may truly represent our surroundings, they bring clarity and objectivity into our analysis.
Last year, the FDA has approved 56 products (57 if we include the first CRISPR/ Cas9 product), making it a remarkable year. If you want to learn more about the subject, here’s a link to a previous publication FDA and EMA 2023 drug approvals- flagships of pharma innovation
In a brief view the major breakthroughs of 2023 were the following:
-????????? 1st CRISPR/Cas9 base drug, Casgevy? to treat sickle cell disease
-????????? 1st FDA approved drug targeting junctional epidermolysis bullosa and dystrophic epidermolysis bullosa Filsuvez?
-????????? 1st drug approval in the US for the treatment of adults with polyneuropathy of hereditary transthyretin-mediated amyloidosis Wainua? (a ligand-conjugated antisense)
-????????? Rivfloza? designed to lower urinary oxalate levels approved in primary hyperoxaluria type 1 and relatively preserved kidney function
-????????? Zurzuvae? a positive allosteric modulator of GABA-A to treat postpartum depression
-????????? 1st ever approved drug to treat Rett syndrome, Daybue?
-????????? 1st ever drug approved Friedreich’s Ataxia (a rare neurodegenerative disease), Skyclarys?
-????????? Yet another Alzheimer’s disease approved therapy Leqembi? the 2nd anti-amyloid approved therapy
The complete package of 56 approved drugs equated to a forecasted value of $75 billion of global sales (considering the sum of sales at pick year), 20 of them expected to reach blockbuster levels (35% of total 2023 drugs approved), by descending date of approval:
1-????? Zilbrysq? (zilucoplan)- Rare/ Orphan diseases
2-????? Zavzpret? (zavegepant)- CNS
3-????? Leqembi? (lecanemab-irmb)- CNS
4-????? Bimzelx? (bimekizumab)- Immunology
5-????? Fabhalta? (iptacopan)- Hematology
6-????? Paxlovid? (nirmatrelvir+ritonavir) - Anti-infectives
7-????? Beyfortus? (nirsevimab-alip)- Anti-infectives
8-????? Zurzuvae? (zuranolone)- CNS
9-????? Veozah? (fezolinetant)- Women's Health
10-? Jaypirca? (pirtobrutinib)- Oncology
11-? Epkinly? (epcoritamab-bysp)- Oncology
12-? Talvey? (talquetamab-tgvs)- Oncology
13-? Defencath? (taurolidine+ heparin)- Anti-infectives
14-? Augtyro? (repotrectinib)- Oncology
15-? Wainua? (eplontersen)- Rare/ Orphan diseases
16-? Truqap? (capivasertib)- Oncology
17-? Omvoh? (mirikizumab-mrkz)- Immunology
18-? Velsipity? (etrasimod)- Immunology
19-? Ngenla? (somatrogon-ghla)- Rare/ Orphan diseases
20-? Brenzavvy? (bexagliflozin)- Metabolic
Lined up with the global market trends, Oncology therapeutic category leads in the number of potential blockbuster status (#5), followed by Immunology, CNS, Rare/Orphan and Anti-infectives in parity (#3), and Women’s Health, Hematology and Metabolic, each with one forecasted blockbuster drug.
When it comes to predictions, this was the overall expectations on the products sales performance. As there is not a crystal ball nor an absolute predictor on the absolute full lifecycle sales. One may reason, how about the performance of these products in its first year after approval.
Sales performance after approval
According to the sales data publicly available, it was possible to evaluate the sales performance of 39 drugs products across the first semester of 2024.
The Oncology field once more meets the expectations leading the sales performance over the first semester by overcoming $700 million within the period. Aligning with the general expected demand for such products, and pricing dynamics.
The Rare/ Orphan space does not disappoint surpassing the $600 million barrier for the time window. Most of the times, these are innovative and only option for a given indication and at a premium pricing (agreeing with the Orphan drug act of 1983). Wherefore larger degree of innovation correlating with market performance.
The Immunology therapeutic area comes in third place of the sales ranking. Once again offering patients a solution to unmet medical needs, overcoming $250 million barrier, on average $136 million per drug (excluding products without available sales data). The tendency for immunology products is to taking some time to capture market share, inasmuch as the treatment guidelines are strict in defining first, second and third line treatment options.
Surprisingly, Ophthalmology which is a niche maket, nonetheless with continuous unmet medical needs, reached $225 million sales in H1 2024. Two of these products Izervay? and Miebo? are not the first line to their indications, Age-related macular degeneration and Dry eye disease, notwithstanding still not completely solved by the current products available. Whereas Xdemvy? is the first ever approved product to treat Blepharitis caused by Demodex spp. Mostly the NCE’s introduction in Ophthalmology faces scarcity each year, albeit the commercial success poised by such innovations in providing a better vision.
Finally, in the three digit million sales, includes Anti-infectives overperforming with around $208 million sales in H1 2024. This type of therapeutic category continuously face many hurdles in the market access. Because the price of many times life saving therapies, though to old and known disease etiologies is not paired to other non-orphan categories, including Oncology and Immunology.
Then below $100 million threshold, Women’s Health presenting itself with $56 million, Kidney diseases $47 million, and finally Cardiovascular $2 million. For all the other therapeutic categories, there is no public data available. On and on, the products are totaling $2.22 billion.
Looking into the sales performance on a product perspective, we may observe the following:
-????????? Bimzelx? (bimekizumab) is the sales leader in 2024, reaching $270 million in H1 2024. The product is indicated to treat moderate to severe?plaque psoriasis. In accordance with the blockbuster forecast (at least $4 billion according to UCB Pharma). The strong sales take-off echos the launch of the product back in H1 2023 in Europe, UK and Japan.
-????????? The second most successful product is Beyfortus? nirsevimab to prevent respiratory syncytial virus hitting $200 million in H1. In agreement with the blockbuster status expected. Even if the product follows seasonality trends.
-????????? The top-3 is completed by Daybue? trofinetide indicated to treat Rett syndrome (Orphan/ Rare diseases, a high unmet medical need expressed by the $160 million sales in the time period. The market penetration for this product is being outstanding as Daybue? is not expected to reach blockbuster levels.
-????????? The forth strongest product ($148.60 million) is Skyclarys?, omaveloxolone, in the Orphan/ Rare space to treat Friedrich’s ataxia.
-????????? While the top-5 is completed by Truqap? capivasertib to treat breast cancer (in a specific disease background), reaching $142 million in H1, another expected blockbuster.
-????????? Fruquintinib Fruzaqla? to treat refractory, metastatic colorectal cancer surprassed the three-digits million sales figures, $130.50 million.
-????????? Still another Oncology product is in the top-10 products of H1 2024, Joenja? leniolisib, $129.70 million to treat activated phosphoinositide 3-kinase delta syndrome.
-????????? Whereas Ojjaara? momelotinib from the Orphan/ Rare space is the last FDA approved product in 2023 to overcome the $100 million, more precisely $111 million.
-????????? The top-10 is completed by Jaypirca? pirtobrutinib a BTK inhibitor in oncology with a $92 million performance in the first semester of 2024. Is it in line to achieve its forecasted blockbuster levels?
-????????? Followed closely by Izervay? avacincaptad pegol an Ophthalmology product targeting age-related macular degeneration, $90 million.
-????????? Other expected blockbusters sales performance throughout H1 2024:
1-????? Epkinly? (epcoritamab-bysp)- Oncology- $63 million
2-????? Leqembi? (lecanemab-irmb)- CNS- $59 million
3-????? Veozah? (fezolinetant)- Women's Health- $47 million
4-????? Wainua? (eplontersen)- Rare/ Orphan diseases- $37 million
5-????? Omvoh? (mirikizumab-mrkz)- Immunology- $35 million
领英推荐
6-????? Zilbrysq? (zilucoplan)- Rare/ Orphan diseases- $16.5 million
7-????? Zurzuvae? (zuranolone)- CNS- $14.8 million
8-????? Augtyro? (repotrectinib)- Oncology- $7 million
9-????? Paxlovid? (nirmatrelvir+ritonavir) - Anti-infectives-$2.29 million
10-? Defencath? (taurolidine+ heparin)- Anti-infectives- $0.81 million
The tables II and III captures these information in a structured way.
The eighteen products without public information on sales performance are the following Filsuvez?, Fabhalta?, Ryzneuta?, Augtyro?, Velsipity?, Rivfloza?, Exxua?, Veopoz?, Elrexfio?, Talvey?, Ngenla?, Posluma?, Rezzayo?, Zavzpret?, Lamzede?, Jesduvroq?, Orserdu? and Brenzavvy?. For more information check table IV below.
Seven of those products have a potential blockbuster expectation, Zavzpret?, Fabhalta?, Talvey?, Velsipity?, Ngenla? and Brenzavvy?. Unfortunately, we couldn’t place it under the microscope of this short report due to the aforementioned absence of publicly available information.
Overall synopsis on the sales performance
This analysis is shedding light on the FDA NCE’s approved right through 2023 and its post-approval sales performance across H1 2024. The information analyzed above should be taken cum grano salis for the reason that the products were not launched at the exact same time.
The main takeaways of this analysis are:
-????????? The leading therapeutic categories are Oncology, Rare/ Orphan and Immunology totaling $1.6 billion
-????????? Immunology and Ophthalmology products have the best rate of total $ sales to number of products, crystalized in Bimzelx? (bimekizumab) sitting at the top of the sales rank, $270 million sales.
-????????? The Rare/ Orphan is still delivering a considerable amount of products (as there is a never ending list of high unmet medical needs) and revenues.
-????????? Ophthalmology products are showing an interesting performance, taking into account that one of the three products is the first ever approved product to treat Demodex blepharitis, Xdemvy? lotilaner.
-????????? The top 10 of products includes 4 Oncology products, 3 Rare/ Orphan diseases drugs, 1 Immunology, 1 Anti-infectives and 1 Ophthalmology.
-????????? The forecasted blockbusters meeting its expectations are Bimzelx? (bimekizumab), Beyfortus? nirsevimab, Truqap? capivasertib and Jaypirca? pirtobrutinib. All above $140 million the threshold with the exception of Jaypirca?, $92 milllion sales in H1 2024.
-????????? The other 10 blockbusters are taking more time to translate the blockbuster potential into actual sales.
-????????? The reasons may include:
1.????? getting through the reimbursement process and/ or inclusion on health insurance script
2.????? indications falling under a strict treatment guidelines
3.????? the seasonality characteristics linked to antiviral products
4.????? the build up of sales teams to enhance the market penetration within the medical community (including Women’s health, Metabolic, Cardiovascular, Renal, CNS), especially in indications with several different options, among others.
-????????? So far in 2024 the FDA has approved 34 new chemical entities, in the homologous period in 2023 FDA was in 40 new products approved. Will it still level till the end of 2024?
-????????? Many of the new products target complete new indications, and using new technologies. Hence continuing the wave of innovation biotech and pharma continuously deliver.
Ergo, the look at the 2023 FDA products approved combining mathematics and reasoning help understand the true value of drugs, most of the times sales are grounded on the direct value to the lives of many patients.
As Plato wrote in the Allegory of the cave under his Republic book, only those who seek the reality under the combined use of mathematics and philosophical dialectic will reach the enlightenment. Without it you are stuck in the deep part of the cave seeing illusions and perceptions.
Reach out to network, commenting or in case you have a specific biotech/ pharma data needs. By sharpening your biotech insights!
#pharma #biotech #innovation #FDA #forecast #sales #RD
Sources:
https://synapse.patsnap.com/article/lexicon-pharmaceuticals-q2-2024-financial-results-and-business-update ??https://www.lexpharma.com/static/fbb4a760d9d6a279bd2a84d26567f99e/10Q_2024Q1.pdf
FDA new drug approvals in Q2 2024 Nature Portfolio https://www.nature.com/articles/d41573-024-00118-z
More exciting innovation coming through 2024 in the New York Times https://www.nytimes.com/2024/09/26/health/fda-schizophrenia-drug.html
The complete guide on 2023 FDA approvals https://www.fda.gov/media/175253/download?attachment