Approval of CRESEMBA® in Argentina
Grupo Biotoscana announces approval of antifungal CRESEMBA® in Argentina.
Montevideo, Uruguay, September 28, 2018. BIOTOSCANA INVESTMENTS S.A. (“Company” or “GBT”) (B3: GBIO33), a leading biopharmaceutical company in Latin America, announces that it has received regulatory approval for Basilea’s antifungal CRESEMBA® (isavuconazole) in Argentina.
CRESEMBA® is approved by ANMAT in Argentina for the treatment of adult patients with invasive aspergillosis and for the treatment of adult patients with mucormycosis for whom amphotericin B is inappropriate. The product is a well differentiated drug that addresses a critical medical need in patients with invasive mold infections.
Centers for Disease Control and Prevention (CDC) defines Aspergillosis as “an infection caused by Aspergillus, a common mold (a type of fungus) that lives indoors and outdoors. Most people breathe in Aspergillus spores every day without getting sick. However, people with weakened immune systems or lung diseases are at a higher risk of developing health problems due to Aspergillus. The types of health problems caused by Aspergillus include allergic reactions, lung infections, and infections in other organs”.
The second indication of CRESEMBA® for Mucormycosis is defined by CDC as “a serious but rare fungal infection caused by a group of molds called mucormycetes. It mainly affects people with weakened immune systems and can occur in nearly any part of the body. It most commonly affects the sinuses or the lungs after inhaling fungal spores from the air, or the skin after the fungus enters the skin through a cut, scrape, burn, or other type of skin trauma”.
GBT is committed to maximizing the value of CRESEMBA® and increasing the benefits provided to patients as well as healthcare providers.
About GBT Grupo Biotoscana
GBT-Grupo Biotoscana (GBT) is a biopharmaceutical group that operates in the fast-growing Latin American region and focuses on rapidly growing market segments such as infectious diseases, oncology and onco-hematology, special treatments, immunology and inflammation and orphan/rare diseases, among others. GBT is currently present throughout 10 Latin American countries where it operates under its companies Biotoscana, United Medical, LKM and DOSA. GBT’s strong portfolio combines world-class licenses and proprietary products. To find out more, please visit www.grupobiotoscana.com.
About CRESEMBA® (isavuconazole)
Isavuconazole is an intravenous (i.v.) and oral azole antifungal and the active agent of the prodrug isavuconazonium sulfate. In the EU and EEA member states, as well as in Argentina, Jordan and Peru, it is approved for the treatment of adult patients with invasive aspergillosis and for the treatment of adult patients with mucormycosis for whom amphotericin B is inappropriate¹. It is also approved in the U.S.² and Switzerland³. Isavuconazole has U.S. and European orphan drug designation for the approved indications.
¹ European Public Assessment Report (EPAR) Cresemba: http://www.ema.europa.eu (Accessed: September 27, 2018)
² In the United States, Cresemba is approved to treat patients 18 years of age and older for invasive aspergillosis and invasive mucormycosis (Cresemba US prescribing information, accessed September 27, 2018).
³ In Switzerland, isavuconazole is approved for the treatment of adult patients with invasive aspergillosis and for the treatment of mucormycosis in adult patients who are resistant to or intolerant of amphotericin B and in adult patients with moderate to severe renal impairment (full indication in: Swissmedic – approved information for healthcare professionals as of August 2017).