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This week we had Eyes on the Amgen data releases for Myasthenia Gravis and Atopic Dermatitis, the BMS approval of Cobenfy for schizophrenia, and Pfizer's voluntary recall of Oxbryta for SCD.
The FDA approved BMS's first-in-class drug KarXT, now known as Cobenfy, to treat schizophrenia.
Cobenfy is the first antipsychotic that specifically targets cholinergic receptors rather than dopamine receptors. Cobenfy has an impact on the muscarinic receptors M1 and M4 and addresses hallucinations, delusions, speech, and emotional output.
About 24 million people worldwide suffer from schizophrenia; of those, about 2.8 million are estimated to be affected in the United States (BMS), with only 1.6 million of those patients receiving treatment. This is mainly because the schizophrenia drugs currently on the market have many side effects, including excessive sedation, weight gain, and movement disorders. About 70% of treated patients eventually stop taking their medication due to these issues. The main side effects of Cobenfy are temporary and manageable with over-the-counter antiemetics for nausea, vomiting, and constipation.
With the approval of a promising new drug, Bristol Myers Squibb’s $14 billion investment in Karuna Therapeutics has paid off after decades of stagnation in the schizophrenia sector. BMS plans to launch by the end of October and anticipates that 80% of its US business will be in Medicare/Medicaid populations. Cobenfy is expected to cost $1,850 a month before discounts or $22,500 annually. This pricing is comparable to that of other branded antipsychotics.
In 2030, Cobenfy may reach a peak of about $2 billion in sales in the United States. If Cobenfy finds other uses in diseases such as Alzheimer’s, the medicine’s maximum potential U.S. revenues might be between $3 billion and $5 billion.
Although BMS’s involvement in neuroscience has been mainly focused on Zeposia in multiple sclerosis in recent years, the company has a strong history in schizophrenia, as demonstrated by the prolonged success of its own antipsychotic Abilify (aripiprazole), which was initially approved by the FDA in 2002.
About a month from now, BMS intends to launch Cobenfy onto the market; the product should be accessible by the end of October. In the next 12 to 18 months, BMS anticipates gaining about 80% of Cobenfy's coverage across Medicare and Medicaid.
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Pfizer has voluntarily withdrawn Oxbryta, Sickle Cell Disease, from the market worldwide.
Pfizer will stop selling Oxbryta, return all manufactured batches, and all ongoing clinical trials, and expanded access programs. According to new clinical data, the drug's overall benefit no longer justifies its risks.
Oxbryta obtained a marketing authorization from the European Commission in 2022 and an accelerated approval from the FDA in late 2019 based on research demonstrating that the treatment was linked to statistically significant improvements in patients’ hemoglobin levels when compared to a dummy medication. The oral therapy was hailed at the time as the first authorized medical intervention that specifically addressed the underlying cause of SCD.
The medication served as the focal point of Pfizers’ $5.4 billion acquisition of Global Blood Therapeutics in 2022. At the time, Pfizer claimed that Oxbryta and GBT's SCD pipeline might reach a combined global peak sales potential of over $3 billion. Oxbryta's global sales revenue was $328 million last year. According to Pfizer, the market removal is not expected to have an impact on their financial guidance for 2024.
There are two approved gene treatments for sickle cell disease (SCD), Vertex and CRISPR Therapeutics’ Casgevy and Bluebird Bio’s Lyfgenia, though uptake has been slow for these new therapies.
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Amgen announces positive data for Uplizna in the MINT trial for gMG and rocatinlimab in eczema.
Patients with the rare autoimmune disease myasthenia gravis (MG) in the current phase 3 MINT research showed a median improvement of 4.2 points on the 24-point activities of daily living scale (MG-ADL) after 26 weeks of treatment, compared to a 2.3-point improvement for those on placebo.
At the beginning of the experiment, those on Uplizna received doses twice, 15 days apart, and then every six months after that. The results demonstrated a clinically and statistically substantial advantage. Amgen are beginning the process of filing regulatory documents to get the medication approved for the treatment of MG.
Other drugs approved for the treatment of MG include Argenx's injectable Vyvgart Hytrulo and AstraZenec’s Soliris.
Uplizna, licensed in 2020 for the treatment of neuromyelitis optica spectrum disease (NMOSD), reported second-quarter sales of $92 million, up from $80 million in the prior quarter. This drug was acquired through Amgen’s $27.8 billion purchase of Horizon Therapeutics in October 2023.
The first phase 3 data on Amgen's $400 million eczema treatment, which links the anti-OX40 antibody to notable symptom improvements, have been made public. However, some analysts say that even if the trial’s main goals were achieved, the biotech company still needs to convince consumers that rocatinlimab has a place in a market alongside Dupixent.
In the POCKET-Horizon trial, 726 patients with moderate-to-severe atopic dermatitis, a type of eczema, were randomly assigned to receive rocatinlimab or a placebo. Compared to 13.7% of patients receiving a placebo, 32.8% of those using rocatinlimab saw a 75% improvement in the area and severity of their eczema after 24 weeks. One of the trial’s main objectives was achieved because of the statistically significant change in EASI-75. Additionally, Amgen observed statistically significant variations in the percentage of patients achieving clear or nearly clear scores on the more exacting rIGA scale compared to the subjective clinician assessment vIGA-AD. 6.6% of the placebo arm and 19.3% of the rocatinlimab group met the response criterion on vIGA-AD. Rocatinlimab and placebo showed 16.4% and 4.9%, respectively, on rIGA.
The fact that Regeneron and Sanofi have already achieved significant success with EASI-75 possibly presents a challenge for Amgen. In two phase 3 trials that backed the FDA’s approval of Dupixent, the area and severity of eczema were 75% improved in 51% and 44% of participants receiving the anti-IL-4Rα antibody. The corresponding numbers for the placebo arms were 12% and 15%. Analysts suggest that Amgen’s statistics are relatively poor compared to competitors.
During a call to review the results, analysts questioned Amgen over the position of rocatinlimab in comparison with Dupixent. Rocatinlimab, a drug with a distinct mode of action, may be able to meet some of the needs in the atopic dermatitis market that other drugs have not, according to Amgen’s senior vice president of worldwide commercial operations, Murdo Gordon.
Amgen included in the trial participants who had taken a biologic like Dupixent in the past. When questioned by an analyst, the business refused to disclose the percentage of patients who had previously been exposed to biologics. Distinguishing between patients who have used biologics before and those who have not could provide a more accurate comparison of rocatinlimab and Dupixent, as well as an indication of the drug’s viability as a second-line treatment.
Among the important information that Amgen is withholding for the time being is a summary of the previous treatments. The company also refused to provide specific information on the rate of fever and chills. Amgen reported that the antibody functioned as anticipated and that any temperature and chill were tolerable and minor. In a previous phase 2b experiment, 11% of patients experienced chills, and 17% experienced fever (pyrexia). In a phase 2b atopic dermatitis trial, Sanofi, which is developing an antibody that targets the OX40 ligand, showed no fever or chills across doses; nevertheless, pyrexia was observed in a phase 2a study.
Amgen believes that it is better to target OX40 than its ligand because, it seems, a biotherapeutic that mutes the OX40 ligand will only suppress OX40 signaling. On the other hand, activating OX40 will eliminate the pathogenic T cell and promote T-cell balance.
Kyowa Kirin received an upfront payment of $400 million from Amgen for the rights to rocatinlimab in 2021. In an effort to gather information that might make rocatinlimab a successful medicine, the biotech is conducting eight pivotal atopic dermatitis trials as part of a comprehensive development program. Two further trials on atopic dermatitis are scheduled to release their results in late 2024 or early 2025.
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