Raltegravir Potassium

The medication works by inhibiting the HIV integrase enzyme. Credit: artem evdokimov / Shutterstock. The UK Medicines and Healthcare products Regulatory Agency (MHRA) has approved the use of Lupin Healthcare and Zentiva Pharma’s generic raltegravir medicines to treat HIV. The 600 mg film‑coated tablet is indicated for use in adults and paediatric patients with a minimum body weight of 40kg. A recommended dosage of 1,200mg raltegravir will be taken as two 600mg tablets once daily. Raltegravir is an antiviral medication that inhibits the HIV integrase enzyme, crucial for the virus’s replication in the body’s cells. When combined with other medicines, raltegravir lowers the HIV viral load in the blood and enhances the CD4-cell count. See Also: Merck secures FDA authorisation for Ebola vaccine Ervebo US proposes rules for drug importation from Canada The MHRA’s endorsement of the generic versions is supported by studies conducted in healthy volunteers, aimed at establishing bioequivalence to the original branded medication. Bioequivalence implies that generic medicines produce identical levels of the active substance in the body as the reference drug. The efficacy and potential side effects of generic raltegravir are expected to mirror those of the reference medicine. The MHRA has committed to maintain vigilant oversight of raltegravir’s safety and effectiveness. Patients are advised to consult their healthcare provider if they encounter adverse effects, including any not listed in the product information leaflets. MHRA Innovative Medicines deputy director Shirley Hopper stated: “Ensuring timely access to generic medicines is a key priority for us. “Appropriate data have been provided to assure us that these medicines are the same as, and considered interchangeable with, an already licensed reference medicine, Isentress. “As with all products, we will keep the safety of raltegravir under close review.”

Almirall expects EBITDA of between €175m and €190m this year. Image credit: Shutterstock/ T. Schneider. Almirall has reported a 6.7% increase in total net sales for the first half of 2024, with the company’s European dermatology business spurring much of the company’s revenue streams. Almirall generated a total of €497.2m ($541.4m) in H1 this year, a year-over-year (YOY) sales increase of 3.2%. The results meant the Spanish pharma reiterated its growth guidance for 2024, estimating an EBITDA of between €175m and €190m, as per a 22 July press release. Shares in the company opened 3.9% higher based on the financial results. Almirall has a €2bn market cap. Almirall’s dermatology business in Europe was the engine for much of the company’s growth, propped up by higher sales of the psoriasis treatment Ilumetri (tildrakizumab) and the recent launch of Ebglyss (lebrikizumab) for atopic dermatitis. In an earnings call on 22 July, Almirall CEO Carlos Gallardo said: “It’s still early days, but we are very encouraged by the strong progress of the product sales [for Ebgylss].” See Also: Rusan Pharma’s API Plant in Ankleshwar Receives USFDA GMP Approval UK MHRA approves Lupin and Zentiva’s raltegravir for HIV Gallardo added that the company expects to “capture a significant share of the advanced therapies market in atopic dermatitis”. Ilumetri, an anti-interleukin-23 (IL-23) antibody, is Almirall’s best-selling product. The drug reached over €100m in sales in H1 this year, representing a 25% increase compared to the same period in 2023. Almirall said it forecasts €250m in peak sales for the drug in 2024. Ilumetri is the European brand name for Ilumya – Almirall having licensed European rights for the drug from Sun Pharma in 2016. European sales for the drug are estimated to reach $300m by 2030, whilst US sales are expected to soar past $1.2bn by the same year, according to analysis by GlobalData. GlobalData is the parent company of Pharmaceutical Technology. Ebgylss meanwhile was recently launched in Germany, the UK, and Norway, and was recommended by England’s National Institute for Health and Care Excellence ( Nice ) for use on the NHS last month. Further rollouts in Denmark, Spain, and Austria are expected later this year for the drug. Almirall licensed the rights to develop and commercialise Ebglyss in dermatology indications, including atopic dermatitis, in Europe from Dermira in 2019. Dermira was then acquired by Eli Lilly, the latter retaining drug rights in the US and the rest of the world. Globally, Ebglyss is forecast to reach blockbuster status by 2026, according to GlobalData’s Pharma Intelligence Centre. Unlike its European counterpart, Almirall’s US dermatology business sales decreased by 4.1%, though CFO Mike McClellan said the business is showing “nearly stable results”, but it is under pressure from “ongoing generic erosion” in the country.