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Optimistic projections are so, well, optimistic. Who’s to say they’ll pan out that way? 

Every year MM+M issues its top crop of launches to watch in the coming months. This time, we’ve followed up to ensure those blue-ribbon picks are actually getting off on the right foot. 

Summarized here are five of the most promising launches of the past year, specifically those that appear to be tracking with their billion-dollar sales forecasts, most with at least one full quarter on market. 

For each compound, we also analyze the keys to success, whether commercial strategy, marketing tactics or competitive circumstances. Readers will find these learnings at the end of each summary.

Write-ups are based on investor notes and other research. Revenue targets and any future approval dates are best estimates as of press time and are subject to change.

1. Merck’s Winrevair (sotatercept) for PAH

Winrevair was greenlit March 26 for treating adults with pulmonary arterial hypertension (PAH), based on compelling results from the Phase 3 STELLAR trial, which showed the treatment led to robust improvements on a six-minute walk test and other metrics. 

Merck says the launch is going well and gaining momentum. Aside from strong payer access on the commercial side, the drug’s debut benefited from a bolus of patients and approval for home administration. It didn’t hurt that the FDA conferred a very broad, clean label. 

“They got everything they wanted [from regulators] with a cherry on top. There couldn’t have been a more favorable label and approval for [Merck] at this point,” as one physician KOL told Leerink analysts earlier this year.

All of that, combined with a higher-than-expected price, enabled Winrevair to get out of the gate quickly. Third-quarter sales came in at $149 million, about double the sales seen in its initial quarter on market, and the product picked up about 3,700 prescriptions. Multiple analysts say sales will easily reach blockbuster status this year, ramping to an incredible $11.4 billion by 2029.

Learning: Merck’s readiness with supply that meets higher-end uptake estimates, plus a buffer, has been key to meeting demand surge. While most if not all of the extenuating circumstances pointed in the company’s favor, near flawless execution — and preparing for the unknowns — has helped it seize the Winrevair opportunity.

2. Madrigal’s Rezdiffra (resmetirom) for NASH/MASH

Madrigal is turning biotech heads with its launch of NASH drug Rezdiffra, which notched an FDA approval March 14 as the first treatment for the liver disease in patients with moderate-to-advanced fibrosis. 

The thyroid-hormone-receptor beta agonist racked up sales of $62.2 million in its first full quarter, with Q4 projected to deliver $94.9 million. 2026 will see revenues hit their stride at $968 million before peaking at $3.5 billion by 2030, according to an estimate from Leerink Partners.

In addition to its strong product profile and first-mover status, the compound has a relatively clean product label. Patients aren’t required to get a liver biopsy or onerous monitoring before starting on Rezdiffra. 

Madrigal hit its coverage goal (greater than 80% of commercial lives) a full quarter ahead of schedule, analysts noted, with the majority of prescriptions being the paid variety versus free or via patient assistance. The drug’s European commercialization plan is set to kick off midway through 2025.

Learning: For now, Rezdiffra has the NASH market all to itself, and it’s capitalized through basic blocking and tackling. Essentials like favorable payer coverage, increased prescriber penetration and uptake among patients with NASH — all achieved at or ahead or schedule — have helped it exploit this enviable position.

3. Janssen’s/Legend Biotech’s Carvykti (cilta-cel) in 2L+ multiple myeloma

Its initial greenlight came back in 2022, but Carvykti took a giant step toward unlocking its blockbuster aspirations this past April. That’s when partners J+J and Legend Biotech scored approval for the therapy’s use in an earlier treatment line.

Already considered the most efficacious of the BCMA CAR-T products in the multiple myeloma market, Carvykti’s line extension — from fifth- to second-line use in adults with relapsed refractory MM — meant thousands more people became eligible.

As a result, revenue spiked 53% between the second and third quarters, from $186 million to $286 million. Sequentially higher growth was expected for Q4, with the brand poised to wrap 2024 — and future years — strong, thanks to the label expansion as well as a manufacturing step-up.

While the hockeystick curve suggests physicians are making Carvykti their preferred second-line option, there’s a threat on the horizon. Arcellx and Kite are developing anito-cel, which eventually could best Carvytki in safety and manufacturing consistency, but it won’t launch before 2026. Meanwhile, many on Wall Street foresee Carvytki U.S. sales well on the way to topping $4 billion by 2030.

Learning: The treatment extension, which made Carvykti the first and so far only BCMA-targeting CAR-T therapy indicated in the second-line setting of MM, was akin to a mini product-launch. To meet the demand, J+J/Legend wisely focused on access, scaling up manufacturing, upping supply and making great strides in raising the number of treatment centers authorized to administer the drug. 

4. Verona’s Ohtuvayre (ensifentrine) for COPD

Just as Verona Pharma secured the FDA nod to market inhalable COPD drug Ohtuvayre in June, its commercial prospects seemed to improve markedly. While Clarivate had forecast a 2029 sales range of $500 million to $750 million, shortly after the approval Truist Securities issued a robust $2.9 billion estimate of peak U.S. sales.

Even that may turn out to be conservative. One reason: Ohtuvayre launched in August at an annual cost of $35,400, far exceeding ICER’s suggested health-benefit price range of $7,500 to $12,700 per year – and the price of existing COPD treatments. 

Another reason for the excitement is that Ohtuvayre is a first-in-class drug with a novel, dual mechanism of action. Its efficacy as a COPD maintenance treatment extends to all severities of the respiratory disease, and it addresses dyspnea, a common COPD symptom in which patients feel short of breath.

So, while many payers may bristle at the cost, the company expects solid coverage of the nebulized drug. When rebates are factored in, insurers are likely to pay less than the list price anyway. Net revenues were $5.6 million for the first seven weeks on market, an encouraging start.

Learning: Although there’s little sales data on which to gauge performance, Ohtuvayre has already become a case study in product differentiation. Buoyed by initial trial data, Verona is initiating a Phase 2 trial to evaluate the treatment’s potential to improve COPD patients’ quality of life when paired with LAMA maintenance therapy. If successful, the additional indication would boost its market impact further.

5. Travere’s Filspari (sparsentan) for IgAN 

Filspari received full approval in September, for slowing kidney function decline in adults with primary IgA nephropathy (IgAN). But like some others on this list, its debut was merely an entrée. A larger opportunity lies ahead, the rare kidney disease FSGS, or focal segmental glomerulosclerosis. 

Filspari in FSGS would be a blockbuster opportunity. It’s an indication for which Travere Therapeutics already made one attempt before being spurned by the FDA due to insufficient data. The firm has already reengaged with regulators and has a meeting scheduled to discuss next steps, including the need for a different clinically relevant endpoint.

Analysts say there’s between a 30% and 60% chance that Filspari crosses the finish line in the U.S. for FSGS in 2025. Meanwhile, the drug rang up third-quarter sales of $35.6 million, beating Wall Street’s prediction of $32.9 million. Its Q4 and full-year forecasts are $38.1 million and $120.6 million, respectively, according to Leerink.

Recently updated IgAN treatment guidelines, which includes a recommendation for Filspari use, should fuel the launch. Likewise, September’s full approval, which followed an accelerated one in 2023, expanded Filspari’s label to a larger addressable patient population. Inclusion of two-year PROTECT data in its product label could spur yet another sales bump.

Learning: Filspari has a long development history. While J.P. Morgan analysts estimate U.S. peak sales in IgAN to be around $500 million, FSGS would tack on an additional billion dollars. That greater payday now appears within reach. Oftentimes, biopharma commercial success depends on establishing momentum early and playing the long game.