Dupixent scores speedy review for rhinosinusitis with nasal polyps; After transplant, third patient is HIV-free for 3 months
→ Regeneron $REGN and Sanofi’s $SNY monoclonal antibody Dupixent — already approved for eczema and asthma — is in line for another approval. The FDA has granted the drug — which made $922 million in net sales last year — priority review for patients with severe chronic rhinosinusitis with nasal polyps, who often see their disease return despite surgery and/or systemic corticosteroids. The US agency is expected to make its decision by June 26.
→ There was palpable excitement earlier this week with the news of a second HIV patient experiencing long-term remission (18 months) following a bone marrow transplant. Although the risky procedure is unlikely going to be used in HIV patients unless they are also riddled with cancer, the plausibility of an HIV cure is tempting. On Tuesday, New Scientist reported that a third individual, dubbed the “Düsseldorf patient,” was found to be HIV-free after three months off antiviral drugs. Apart from the three reported cases, there are two patients that have undergone a bone marrow transplant but haven’t stopped taking antiviral medications yet, the report said.
→ Weeks after TG Therapeutics nabbed breakthrough therapy status for its experimental cancer drug umbralisib, the drug developer said data safety boards had given the company the green light to continue evaluating the compound in two trials — the UNITY-CLL Phase III study and the UNITY-NHL Phase IIb trial — as planned. “…the DSMBs, which collectively evaluated safety data from over 750 patients treated with umbralisib, did not raise any safety concerns and recommended that both the UNITY-CLL and the UNITY-NHL trials continue unmodified,” chief Michael Weiss said in a statement. The New York-based company’s stock $TGTX jumped about 9.4% to $6.65 in pre-market trading.