The US Food and Drug Administration (FDA) said it approved 21 New Molecular Entities (NMEs) in 2003, up from 17 a year earlier. And the increasing importance of the biotechnology sector was reflected by the fact that last year, for the first time, the agency received more submissions for biologics than for traditional pharmaceutical medicines.
Priority approvals - for drugs which are considered to answer an unmet medical need - also increased over 2002, from seven to nine, said the FDA.
Highlights of this year's crop included Roche and Trimeris' Fuzeon (enfuvirtide) injection for the treatment, in combination with other antiretroviral agents, of HIV-1 infection. This is the first drug in the HIV entry inhibitor class to reach the market.
Among the new biologics was Biogen Idec's antibody-based drug Amevive (alefacept), which became the first biological approved for the treatment of psoriasis. Also debuting was Corixa/GlaxoSmithKline's Bexxar (tositumomab), a radio-labelled monoclonal antibody available for the treatment of patients with CD20-positive follicular non-Hodgkin's lymphoma.
Other US introductions included:
- Merck & Co's Emend (aprepitant) capsules for use in combination with other antiemetic agents for the prevention of nausea and vomiting in chemotherapy;
- AstraZeneca's Iressa (gefitinib) tablets for the treatment of non-small cell lung cancer;
- Millennium Pharmaceuticals and Johnson & Johnson's Velcade (bortezomib) injection for the treatment of multiple myeloma;
- Bristol-Myers Squibb's Reyataz (atazanavir) capsules for combination treatment of HIV-1;
- Cubist Pharmaceuticals' Cubicin (daptomycin) injection for the treatment of complicated skin and skin structure infections;
- Fabrazyme (agalsidase beta) for use in patients with Fabry disease to reduce GL-3 deposition in kidney cells;
- BioMarin/Genzyme's Aldurazyme (laronidase) for treatment of patients with Hurler, Hurler-Scheie and Scheie forms of mucopolysaccharidosis I (MPS I);
- Aventis Behring's Zemaira (human alpha-1-proteinase inhibitor) for use in individuals with alpha-1-antitrypsin deficiency and evidence of emphysema;
- MedImmune/Wyeth's FluMist (an influenza vaccine that is the first nasally administered vaccine to be marketed in the US); and
- BabyBig (human botulism immune globulin intravenous), developed by the California Department of Health Services, for treatment of infant botulism caused by type A or type B Clostridium botulinum.
Meanwhile, outside the US, 2003 also saw debuts for ImClone Systems' epidermal growth factor receptor inhibitor Erbitux (cetuximab). This was launched in Switzerland last December by licensee Merck KGaA for use in combination with irinotecan for the treatment of patients with metastatic colorectal cancer.