Dermatology

Nemluvio is a first-in-class IL-31 inhibitor that the US FDA approved for prurigo nodularis. 

New pivotal data on Regeneron and Sanofi’s antibody in chronic urticaria are underwhelming, though probably sufficient for approval. A green light may beckon in bullous pemphigoid, too.

The Danish firm’s dermatology products have made significant strides in the past six months, leading to an upwards revision of its sales forecast for full-year 2024.

The second instalment of In Vivo’s three-part series delves into the therapeutic categories that will propel forecast pharmaceutical sales growth for 2025, focusing on blood malignancies, skin conditions and generalized cardiovascular disease.

TMB-001, a topical formulation of isotretinoin, missed its primary endpoint in the ASCEND study and will not be filed for approval. Leo is turning its attention to hand eczema and dealmaking.

Mentholatum says two line extensions made with 2% salicylic acid and its "Oxy for Every Kind of Ne" campaign reinforce the brand’s “commitment to tackling every type of acne—from face-ne and chin-ne to body-ne.”

The group has stopped further development of the IL-17A inhibitor in hidradenitis suppurativa and psoriatic arthritis, and intends to pivot to a thyroid eye disease therapy.  

The European Medicines Agency has started reviewing new marketing applications for 10 products, including Blenrep, GSK’s previously approved multiple myeloma drug that was withdrawn from the market, and vimseltinib, which could become the EU’s first oral treatment approved for TGCT.

Nine new entries targeting a wide range of unmet medical needs. Several EU marketing approvals and two withdrawals. And an accelerated assessment tool that was seldom used. These were among the activities noted as part of the European Medicines Agency’s priority medicines scheme during the first half of 2024.

After a quiet July, August and September are shaping up to be busy on the approvals front. Already this month, the US FDA has approved Adaptimmune’s Teclera for synovial sarcoma, Phathom’s Voquezna for gastro-esophageal reflux disease and Servier’s Voranigo for gliomas. Here, Scrip takes a look at ten other approvals for novel products in the offing for the third quarter.    

Two orphan drugs are among a host of products that the European Medicines Agency’s human medicines committee has OKd for pan-EU approval.

The JAK inhibitor cream for hand eczema will serve a large market in Europe and help the Danish dermatology specialist expand its strong position in dermatology.   

Eisai/Biogen could this week learn whether the European Medicines Agency will give the thumbs up to market lecanemab across the EU for early Alzheimer’s disease.

The Barcelona-headquartered group’s Lilly-partnered atopic dermatitis drug is enjoying a decent launch in Germany and reimbursement has just been secured in the UK.

Two older drugs – Cosentyx and Entresto – continue to drive growth at the Swiss giant, while Leqvio is finally making its mark on the sales front.

A third US FDA approval for its skin drug is putting Zoryve into a strong position to become the preferred topical brand in dermatology, claims CEO Frank Watanabe.

Regeneron, whose blood cancer treatment odronextamab was recently turned down by the US regulator but not for reasons relating to efficacy or safety, could soon learn whether its product will be among the drugs to get the thumbs up from the CHMP, the European Medicines Agency’s human medicines committee.

In this week's podcast edition of Five Must-Know Things: the outlook for 2025 launches; Merck confident in new pneumococcal vaccine; multiple US setbacks for Japanese firms; Stock Watch on Moderna missteps; and Sun’s North America head talks plans and strategy.

Academia-developed novel oral PAI-1 inhibitor in combination with Opdivo showed a strong response rate in PD-1 treated melanoma patients with certain disease characteristics and could represent a new breakthrough for a class with no clinical stage competitors. 

Vyluma’s eyedrop for treating myopia in children and Vertex’s next-generation triple combination treatment for cystic fibrosis are among the latest drugs that the European Medicines Agency has begun reviewing for potential EU marketing approval.